Incontinence treatment device having a first anchor assembly and a second anchor assembly

ABSTRACT

An incontinence treatment device has first and second anchor assemblies. At least one of the first anchor assembly and the second anchor assembly is adjustable along the device and has a collar disposed over a body with a strand coupled to the device and located between the body and the collar.

This application is a Continuation of prior application Ser. No.15/632,429 filed on Jun. 26, 2017, which is a Continuation-in-Part ofprior application Ser. No. 14/754,757, filed on Jun. 30, 2015, now U.S.Pat. No. 9,717,581, which is a Continuation-in-Part of prior applicationSer. No. 14/181,607, filed on Feb. 14, 2014, now U.S. Pat. No.9,370,363, which is a Continuation-in-Part of prior application Ser. No.12/717,957, filed Mar. 5, 2010, now U.S. Pat. No. 8,696,544, which is aContinuation-in-Part of prior application Ser. No. 12/621,517, filed onNov. 19, 2009, now U.S. Pat. No. 8,585,579, which prior application wasa Continuation-in-Part of prior application Ser. No. 12/414,709, filedon Mar. 31, 2009, now U.S. Pat. No. 8,585,578, which claimed the benefitof U.S. Provisional Application No. 61/150,276, filed on 5 Feb. 2009.

TECHNICAL FIELD

This disclosure relates generally to medical devices. More particularly,this disclosure relates to implantable devices, tools, and methods foranatomical support.

BACKGROUND

Devices for anatomical support, and particularly those for treatment ofurinary incontinence and pelvic organ prolapse have been proposed inrecent years. Such devices have included suburethral sling devices forurinary incontinence, and mesh devices for pelvic organ prolapse. Slingdevices are surgically implanted under a patient's urethra to providesupport to the urethra so that during a provocative event such ascoughing or laughing, urine is inhibited from leaking out of theurethra. Devices for treatment of pelvic organ prolapse are alsosurgically implanted, to inhibit herniation or prolapse of an organ(e.g., the bladder) into the vaginal space. Such support from the slingand mesh devices replaces natural anatomical support that is lacking inthe patient. But implanting and anatomically securing some devices maybe difficult and time consuming. Further, in the case of urinaryincontinence, some sling devices may provide unreliable anatomicalfixation and unacceptable adjustment or tensioning for supporting theurethra, thereby leading to suboptimal or even unacceptable results fortreatment of urinary incontinence.

SUMMARY

This disclosure describes novel implantable devices that provide supportto a urethra or other anatomical structure. This disclosure alsodescribes novel tools and methods for use with the implantable devices.

In one aspect, an implantable device for anatomical support includes asling, a first interconnecting member that is coupled to the sling, anda second interconnecting member that is coupled to the sling. Anadjustable anchor is slidably coupled to the first interconnectingmember to permit bi-directional movement along the first interconnectingmember, and configured to exert a compressive force generatingfrictional interference between the adjustable anchor and the firstinterconnecting member, to inhibit the bi-directional movement of theadjustable anchor along the first interconnecting member unlesssufficient force is applied to overcome the frictional interference.Also, a fixed anchor is fixedly coupled to the second interconnectingmember. In another aspect, the first interconnecting member and thesecond interconnecting member are sutures. In another aspect, the firstinterconnecting member and the second interconnecting member arematerials having an overall width approximating that of a surgicalsuture.

In another aspect, an implantable device for anatomical support includesa sling, a first interconnecting member that is coupled to the sling,and a second interconnecting member that is coupled to the sling. Ananchor is provided in freely sliding engagement with the firstinterconnecting member. A tensioning element is slidably coupled to thefirst interconnecting member to permit movement along the firstinterconnecting member and configured to exert a compressive forcegenerating frictional interference between the tensioning element andthe first interconnecting member, to inhibit the movement of thetensioning element along the first interconnecting member unlesssufficient force is applied to overcome the frictional interference.Also, a fixed anchor is fixedly coupled to the second interconnectingmember. In another aspect, the first interconnecting member and thesecond interconnecting member are sutures. In another aspect, the firstinterconnecting member and the second interconnecting member arematerials having an overall width approximating that of a surgicalsuture.

In another aspect, an implantable device for anatomical support includesan anatomical support member and an interconnecting member that iscoupled to the anatomical support member. An adjustable anchor isslidably coupled to the interconnecting member to permit bi-directionalmovement along the interconnecting member and configured to exert acompressive force generating frictional interference between theadjustable anchor and the interconnecting member, to inhibit thebi-directional movement of the adjustable anchor along theinterconnecting member unless sufficient force is applied to overcomethe frictional interference. In another aspect, the anatomical supportmember is a shaped mesh material for treatment of prolapse. In anotheraspect, the interconnecting member is a suture. In another aspect, theinterconnecting member is a material having an overall widthapproximating that of a surgical suture.

In another aspect, an implantable device for anatomical support includesan anatomical support member, an interconnecting member that is coupledto the anatomical support member, and an anchor in freely slidingengagement with the interconnecting member. A tensioning element isslidably coupled to the interconnecting member to permit movement alongthe interconnecting member and configured to exert a compressive forcegenerating frictional interference between the tensioning element andthe interconnecting member, to inhibit the movement of the tensioningelement along the interconnecting member unless sufficient force isapplied to overcome the frictional interference. In another aspect, theinterconnecting member is a suture. In another aspect, theinterconnecting member is a material having an overall widthapproximating that of a surgical suture.

In another aspect an adjustable anchor, for use with an anatomicalsupport member having an interconnecting member extending therefrom,includes a body having a proximal end and a distal end, wherein thedistal end includes a flange section that is wider than the proximalend. A collar surrounds, and generates a compressive force against, theproximal end of the body, wherein the interconnecting member is disposedbetween the body and the collar, subject to the compressive force thatgenerates frictional interference to inhibit bi-directional movement ofthe adjustable anchor along the interconnecting member unless sufficientforce is applied to overcome the frictional interference. In anotheraspect, a plurality of flanges protrude from the flange section,separated by webs. In another aspect, at least one flange has an anglededge. In another aspect, at least one web is self-creasing.

In another aspect an adjustable anchor and a tool, for placing in apatient an anatomical support member having an interconnecting memberextending therefrom, includes an anchor body having a proximal end, adistal end, and a channel extending longitudinally through the anchorbody, wherein the distal end includes a flange section that is widerthan the proximal end. An anchor collar surrounds, and generates acompressive force against, the proximal end of the anchor body, whereinthe interconnecting member is disposed between the anchor body and theanchor collar, subject to the compressive force that generatesfrictional interference to inhibit bi-directional movement of theadjustable anchor along the interconnecting member unless sufficientforce is applied to overcome the frictional interference. A tool shafthas a proximal end, a shoulder, and a distal tip proximate the shoulder.A helical curve in the shaft terminates at the shoulder. The distal tipis configured to be placed in the channel through the anchor body suchthat the shoulder abuts the anchor body adjacent to the flange section.The helical curve is configured to guide the distal tip from a vaginalincision, around a descending ramus, and through an obturator foramen.In another aspect, a handle is coupled to the proximal end.

In another aspect a surgical method is provided for use with (i) animplantable device having an anatomical support member, a fixed anchorcoupled to the implantable device, an adjustable anchor, and aninterconnecting member that couples the implantable device to theadjustable anchor in frictional sliding engagement, (ii) a first toolcorresponding to a first side of a patient, and (iii) a second toolcorresponding to a second side of a patient. The method includesplacement of the fixed anchor on a distal tip of the first tool. Avaginal incision in the patient is entered with the fixed anchor on thedistal tip of the first tool. The first tool is rotated in a directioncorresponding to the first side of the patient such that the fixedanchor travels in a path around a descending pubic ramus on the firstside of the patient, continuing in the path until the fixed anchor isplaced in obturator tissue on the first side of the patient; and thefirst tool is removed from the patient. An adjustable anchor is placedon a distal tip of the second tool. The vaginal incision in the patientis entered with the adjustable anchor on the distal tip of the secondtool. The second tool is rotated in a direction corresponding to thesecond side of the patient such that the adjustable anchor travels in apath around a descending pubic ramus on the second side of the patient,continuing in the path until the adjustable anchor is placed inobturator tissue on the second side of the patient; and the second toolis removed from the patient. The interconnecting member, in frictionalsliding engagement with the adjustable anchor, is pulled to adjust alength of the interconnecting member between the anatomical supportmember and the adjustable anchor.

In another aspect an implantable anatomical support includes a supportbody and at least three arms extending from the support body, aninterconnecting member that is coupled to one each of at least two ofthe arms extending from the support body, and an adjustable anchorslidably coupled to each of at least two of the interconnecting members.The adjustable anchor is configured to permit bi-directional movementalong the interconnecting member and configured to exert a compressiveforce generating frictional interference between the adjustable anchorand the interconnecting member to inhibit the bi-directional movement ofthe adjustable anchor along the interconnecting member unless sufficientforce is applied to overcome the frictional interference.

Another aspect provides a method of addressing pelvic dysfunction in apatient. The method includes forming an incision, and placing an anchorthat is attached to a support member by an interconnecting member onto adistal tip of a tool. The method additionally includes inserting thedistal tip of the tool and the anchor into the incision, guiding theanchor to an obturator foramen, and pushing the anchor through amembrane extending over the obturator foramen. The method furtherincludes adjusting the support member by sliding the interconnectingmember relative to the anchor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of one embodiment of an implantable device foranatomical support.

FIG. 2 is an exploded illustration of a component of the implantabledevice shown in FIG. 1.

FIG. 3 is an exploded illustration of another component of theimplantable device shown in FIG. 1.

FIG. 4 is an assembled, top view of the component shown in FIG. 3.

FIG. 5 is an illustration of the implantable device shown in FIG. 1,after implantation in a patient.

FIG. 6 is an illustration of another embodiment of an implantable devicefor anatomical support.

FIG. 7 is a magnified illustration of components of the implantabledevice shown in FIG. 6.

FIG. 7A is a cross-sectional view of components shown in FIG. 7, takenalong lines 7A-7A.

FIG. 8 is a magnified illustration of one of the components shown inFIG. 6.

FIG. 8A is a top view of the component shown in FIG. 8.

FIG. 9 is a magnified illustration of an alternative component for thedevice shown in FIG. 6.

FIG. 9A is a top view of the component shown in FIG. 9.

FIG. 10A is a partial illustration of another embodiment of animplantable device for anatomical support.

FIG. 10B is an illustration of another embodiment of an implantabledevice for anatomical support.

FIG. 10C is an illustration of another embodiment of an implantabledevice for anatomical support

FIG. 11 is an illustration of one embodiment of a pair of tools for usein a surgical method to place an anatomical support member in a patient.

FIG. 12 is a magnified, partial illustration of one of the tools shownin FIG. 11, coupled to a component shown in FIG. 1.

FIG. 13 is a top view of one embodiment of an implantable anatomicalsupport device.

FIG. 14 is a top view of one embodiment of an implantable anatomicalsupport device.

FIG. 15 is a top view of one embodiment of an implantable anatomicalsupport device.

FIG. 16 is a top view of one embodiment of a system for addressingpelvic dysfunction in a male including an adjustable support member andan introducer tool.

FIG. 17 is a top view of the adjustable support member illustrated inFIG. 16.

FIG. 18A is a side view of the introducer tool illustrated in FIG. 16,and FIG. 18B is a close-up view of a distal tip of the tool.

FIG. 19 is a schematic view of an inside-out insertion path for the toolentering through an incision and piercing an obturator foramen of thepatient for placement of trans obturator arms of the support member.

FIG. 20 is a schematic view of an insertion path for the tool taking anoptional suprapubic approach from the abdomen down to the incision forplacement of suprapubic arms of the support member.

FIG. 21 is a schematic view of one embodiment of the adjustable supportmember illustrated in FIG. 17 as implanted via a single incision.

FIG. 22A is a perspective view of one embodiment of a support memberincluding an adjustable anchor and a hanger.

FIG. 22B is a side view and FIG. 22C is a front view of the hangerillustrated in FIG. 22A.

FIG. 23 is a schematic view of one embodiment of the support memberillustrated in FIG. 22 implanted via a single incision with theadjustable anchor inserted in a membrane of an obturator foramen and thehanger secured over a portion of a ramus to allow the support member toalleviate pelvic dysfunction.

FIG. 24 is a top view of one embodiment of a support member includingadjustable anchors and hangers and implantable via a single incision.

FIG. 25 is a schematic view of one embodiment of the adjustable anchorsof FIG. 24 anchored to membranes of obturator foramen and the hangerssecured to the pelvis.

FIG. 26 is a schematic view of a pair of adjustable supports asillustrated in FIG. 1 implanted into a patient via a single incision toalleviate pelvic dysfunction.

FIG. 27 is a top view of one embodiment of a tissue anchor systemincluding a support material, an anchor assembly, and an introducer.

FIG. 28 is a perspective view of one embodiment of the introducerillustrated in FIG. 27.

FIG. 29 is a perspective view of the introducer illustrated in FIG. 28.

FIG. 30 is a perspective view of an end portion of a cannula of theintroducer illustrated in FIG. 28.

FIG. 31 is a top view, FIG. 32 is a side view, and FIG. 33 is across-sectional view of the cannula of the introducer illustrated inFIG. 28.

FIG. 34 is a perspective view and FIG. 35 is a side view of oneembodiment of the anchor assembly illustrated in FIG. 27.

FIG. 36 is a perspective view of one embodiment of the anchor assemblyillustrated in FIG. 27.

FIG. 37 is a perspective view of one embodiment of an anchor suitablefor use with the tissue anchor system illustrated in FIG. 27.

FIG. 38 is a top view and FIG. 39 is a bottom view of the anchorillustrated in FIG. 37.

FIG. 40 is cross-sectional view of the leading end portion of the anchorand FIG. 41 is cross-sectional view of the trailing end portion of theanchor.

FIGS. 42-43 are perspective views of the anchor illustrated in FIG. 37ejected into soft tissue from the cannula illustrated in FIG. 30.

FIGS. 44-46 are schematic views of the anchor illustrated in FIG. 37rotated into engagement with tissue.

FIGS. 47A-47J are schematic views of embodiments of a process forimplanting the tissue anchor system illustrated in FIG. 27 in a personto treat urinary incontinence.

FIG. 48 is a top view of one embodiment of a tissue anchor systemincluding two toggling anchors and two adjustable anchors attached to asupport material.

FIG. 49 is a top view of one embodiment of a tissue anchor systemincluding four adjustable anchors attached to a support material.

DETAILED DESCRIPTION

One embodiment of an implantable device for anatomical support (device10) is illustrated in FIG. 1. Therein, an anatomical support member in aform of a suburethral sling includes anchors that are deployed into apatient's tissues. The anchors are coupled to the sling byinterconnecting members. In this regard a fixed anchor is fixedlyconnected in fixed relation to the sling by a first interconnectingmember, and an adjustable anchor is slidably coupled in adjustablerelation to the sling by a second interconnecting member. The adjustableanchor, as will be described, is configured to permit bi-directionalmovement along the second interconnecting member in frictional slidingengagement therewith. In one embodiment, the interconnecting members arelengths of suture or suture-like material.

With particular reference to FIGS. 1 and 2, an example of device 10includes a suburethral sling 100 with opposing ends 102 and 104. Device10 also includes interconnecting member 110 having opposing ends 112 and114, and interconnecting member 129 having opposing ends 130 and 134.End 112 of interconnecting member 110 is coupled to end 1502 of sling100; and as shown in FIG. 2 end 130 of interconnecting member 129 iscoupled to end 104 of sling 100. Although shown in the drawings viaphantom lines as being coupled to an underside or bottom surface ofsling 100, it is to be understood that the coupling of interconnectingmembers 110 and 129 to sling 100 may be provided at any suitable surfaceof sling 100 and at any suitable orientation thereon.

Also as shown in FIG. 2, in one embodiment device 10 includes a fixedanchor 136 having a body 122 with a proximal end and a distal end, and achannel 124 extending longitudinally therethrough. A plurality offlanges 126 protrude from the distal end, separated by webs 127. End 134of interconnecting member 129 is fixedly coupled to body 122. Fixedanchor 136 also includes a collar 138. When assembled for use in device10 as shown in FIG. 1, collar 138 covers the proximal end of body 122 offixed anchor 136 and end 134 of interconnecting member 129 coupled tobody 122.

Device 10 also includes an adjustable anchor 120. Referring to FIGS. 3and 4, in one embodiment adjustable anchor 120 includes a body 122having a proximal end and a distal end, with a channel 124 extendinglongitudinally therethrough and a plurality of flanges 126 protrudingfrom the distal end that are in turn separated by webs 127. As shown inFIG. 3 in exploded half-section, and in a top assembly view in FIG. 4,adjustable anchor 120 has a collar 128 surrounding the proximal end thatincludes a pair of apertures 128A and 128B. When assembled for use indevice 10, collar 128 covers body 122 of adjustable anchor 120 whileapertures 128A-B in collar 128 permit passage of interconnecting member110 therethrough in frictional sliding engagement with adjustable anchor120. In this regard and with reference to FIG. 4, it is to beappreciated and understood that interconnecting member 110 is disposedthrough aperture 128A of collar 128, around a partial circumference ofbody 122, and through aperture 128B of collar 128. By virtue of anintentionally close fit to exert a compressive force and thus frictionalinterference between interconnecting member 110, collar 128, and body122, adjustable anchor 120 is slidably coupled to interconnecting member110 to permit bi-directional movement along interconnecting member 110upon overcoming such frictional interference.

It is to be understood that an amount of compressive force and thusdesired frictional interference could be varied among embodiments ofadjustable anchor 120 with regard to an elasticity of a particularmaterial chosen for collar 128 and also with regard to placement ofapertures 128A and 128B in collar 128. For example, with locations ofapertures 128A-B being constant, if a material chosen for collar 128 ina first embodiment of adjustable anchor 120 has less elasticity than amaterial chosen for collar 128 in a second embodiment of adjustableanchor 120, then the compressive force and resulting frictionalinterference of the first embodiment would be greater than that of thesecond embodiment due to, comparatively, greater resistance of collar128 against interconnecting member 110 in the first embodiment than inthe second embodiment. Similarly, with a material for collar 128 beingconstant, if apertures 128A-B are placed farther apart in one embodimentof anchor 120 than in a second embodiment of anchor 120, then thecompressive force and resulting frictional interference of the firstembodiment would be greater than that of the second embodiment due to,comparatively, a longer path through adjustable anchor 120 ofinterconnecting member 110 in the first embodiment than in the secondembodiment.

This feature of frictional sliding engagement between interconnectingmember 110 and adjustable anchor 120 enables adjustment and tensioningof sling 100 when implanted in a patient. Referring to FIG. 5, oneembodiment of device 10 is illustrated as having been implanted in apelvic region P of a patient that includes urethra U and obturatortissue OT in each obturator foramen OF. In the drawing suburethral sling100 of device 10 is shown as having been positioned under the patient'surethra U, with placement of fixed anchor 136 in obturator tissue OT ofone obturator foramen OF and placement of adjustable anchor 120 inobturator tissue OT in the other obturator foramen OF. If desired,positions of anchors 120 and 136 could be exchanged in a left and rightsense relative to pelvic region P. As will be further described, flanges126 and webs 127 of anchors 120 and 136 secure the placement of eachanchor in respective obturator tissue OT; and in one embodiment, atleast one flange 126 has an angled or beveled edge 126E to promote suchsecure placement in obturator tissue OT or other anatomical tissue.

In one embodiment, at least one web 127 is self-creasing. Specifically,upon application of pressure to flange 126 such as when anchors 120 and136 are being deployed through and secured at selected anatomicaltissue, web 127 tends to fold or crease which thereby tends tofacilitate, advantageously, a temporary bending or deflection of anadjacent flange 126 downwardly and inwardly toward longitudinal channel124. In turn, this downward or inward bending or deflection of flange126 tends to facilitate such deployment of the anchor through and intothe tissue. Furthermore, upon such deployment through tissue, web 127advantageously tends to inhibit an inverse bending or deflection offlange 126 upwardly toward body 122.

By way of the coupling of interconnecting members 110 and 129 to anchors120 and 136 respectively, and the coupling of interconnecting members110 and 129 to ends 102 and 104 of sling 100 respectively, sling 100 ismaintained in position as desired under urethra U. With fixed anchor 136and adjustable anchor 120 so implanted in obturator tissue OT, and withregard to the frictional sliding engagement between interconnectingmember 110 and adjustable anchor 120, it is to be particularlyunderstood that pulling on end 114 of interconnecting member 110 awayfrom adjustable anchor 120 with a force sufficient to overcome theaforementioned interference force between interconnecting member 110 andadjustable anchor 120 would cause interconnecting member 110 to passthrough anchor 120 with a resultant shortening of a distance between end1502 of sling 100 and adjustable anchor 120. Thereby, sling 100 would beraised or elevated under urethra U as may be desired and as will befurther described. Conversely, pulling on end 112 of interconnectingmember 110 away from adjustable anchor 120 (or pulling on sling 100 awayfrom anchor 120, or so pulling on both end 112 and sling 100) with suchforce would overcome the interference and cause interconnecting member110 to pass in an opposite direction through anchor 120 with a resultantlengthening of a distance between end 1502 of sling 100 and adjustableanchor 120. Thereby, sling 100 would be lowered under urethra U as maybe desired and as will be further described.

It is to be appreciated and understood that the novel construction andoperation of device 10 is to be provided with respect to three forceparameters. First, device 10 is to be constructed such that adjustableanchor 120 is not destroyed or otherwise damaged upon frictional slidingmovement of interconnecting member 110 through anchor 120. Second,device 10 is to be constructed such that neither fixed anchor 136 nor,particularly, adjustable anchor 120 are pulled out or dislodged fromobturator tissue OT into which they have been placed and secured, uponmovement of interconnecting member 110 through adjustable anchor 120during intraoperative adjustment. Third, device 10 is to be constructedsuch that the aforementioned interference force between interconnectingmember 110 and adjustable anchor 120 is sufficiently high to inhibitmovement of sling 100 under urethra U during a provocative event such ascoughing by the patient when internal anatomical forces are exerted upondevice 10.

In one embodiment, sling 100 has a length of about 7 cm (2.76 in.) and awidth in a range of about of 8 mm (0.315 in.) to 11 mm (0.433 in.).Further, in one embodiment sling 100 is a medical grade material suchas, for example, knitted polypropylene ARIS® brand mesh material that iscommercially available from Coloplast A/S; and interconnecting members110 and 129 are lengths of medical grade suture or suture-like materialsas aforementioned. In another embodiment, interconnecting members 110and 129 could be, for example, the aforementioned polypropylene materialof sling 100 that has been knitted, woven, or otherwise formed into anelongated suture-like filamentary material. In another embodimentinterconnecting members 110 and 129 could be, variously alone ortogether, continuations of the material of sling 100 configured to havecharacteristics of a suture-like filamentary material. Accordingly, suchembodiments would provide a material having an overall widthapproximating that of a surgical suture.

Anchors 120 and 136 could be manufactured using any suitable materialssuch as polypropylene and polyurethane, and fabrication techniques suchas molding and milling. In one embodiment, body 122, flanges 126, andwebs 127 are fabricated from polypropylene. In one embodiment, collar128 is molded from a thermoplastic polyurethane material or polymericelastomer such as TECOTHANE® brand material. In one embodiment, anchors120 and 136 have an overall length of 0.622 cm (0.245 in.) and a maximumwidth at flanges 126 of 0.470 cm (0.185 in.). In one embodiment, flanges126 have a width of 0.114 cm (0.045 in.) and a thickness of 0.038 cm(0.015 in.). In one embodiment, webs 127 have a thickness ofapproximately one-half that of flanges 126, or about 0.019 cm (0.008in.). In one embodiment, body 122 has a length of 0.312 cm (0.123 in.)and a diameter of 0.172 cm (0.068 in.). In one embodiment, longitudinalchannel 124 in body 122 has a diameter of 0.097 cm (0.038 in.). In oneembodiment, before being assembled as described below, collar 128 has aninner diameter of 0.127 cm (0.050 in.), an outer diameter of 0.254 cm(0.100 in.), and a length of 0.318 cm (0.125 in.); and apertures 128A-Bhave a diameter of 0.051 cm (0.020 in.). In one embodiment, collar 138of anchor 136 has an inner diameter of 0.191 cm (0.075 in.), an outerdiameter of 0.254 cm (0.100 in.), and a length of 0.254 cm (0.100 in.).

In one example of construction of device 10, with reference again toFIG. 2, end 112 of interconnecting member 110 is sonically welded to end1502 of sling 100; and end 134 of interconnecting member 129 issonically welded to end 104 of sling 100. Further in this example, end134 of interconnecting member 129 is placed against body 122 of anchor136, and collar 138 is placed over body 122 and end 134. Those assembledcomponents are then sonically welded, thereby securing interconnectingmember 129 to anchor 136.

Regarding assembly of adjustable anchor 120, in one embodiment collar128 is swelled by using a suitable solvent such as methylethylketone (orMEK; also referred to as butanone). Collar 128, manufactured from thethermoplastic polyurethane material as aforementioned, is immersed inthe MEK for approximately four hours whereupon it swells or becomesenlarged due to infiltration of the MEK into a molecular composition ofthe polyurethane material causing its expansion in all dimensions.Swelled collar 128 is then loosely placed over body 122 of adjustableanchor 120, and as aforementioned end 114 of interconnecting member 110is then passed through aperture 128A of collar 128, around a partialcircumference of body 122, and through aperture 128B such that a segmentof interconnecting member 110 is within apertures 128A-B. In anotherembodiment interconnecting member 110 is placed through apertures 128Aand 128B of swelled collar 128 such that a segment of interconnectingmember 110 is within apertures 128A-B, and then collar 128 is placedover body 122 of adjustable anchor 120. That assembly is then raised toa temperature of 30 C for approximately 24 hours, to accelerateevaporation of the MEK from the thermoplastic polyurethane material.When the MEK evaporates, the swelling of collar 128 decreases,effectively returning collar 128 to its pre-swelled dimensions. Thereby,collar 128 tightly surrounds body 122 and interconnecting member 110disposed therebetween. A result of such assembly is that interconnectingmember 110 is movable through apertures 128A-B of collar 128, infrictional sliding contact between body 122 and an inside surface ofcollar 128.

Although a path through apertures 128A-B is illustrated as beingperpendicular to longitudinal channel 124, one aperture 128A or 128Bcould be at a higher or lower point on collar 128 than the otheraperture and thus the path through apertures 128A-B could be at anotherangle relative to channel 124.

Also, it is to be understood that the aforedescribed connections ofcomponents by sonic welding could instead be accomplished by any othersuitable means such as, for example, by use of a suitable adhesivematerial.

In another embodiment, anchor 136 could be coupled directly toanatomical support member 100. In such an embodiment, interconnectingmember 129 could be omitted and end 104 could be, for example, sonicallywelded, glued, or otherwise mechanically coupled to anchor 136 betweenan outside surface of body 122 and an inside surface of collar 128. Inanother embodiment, collar 128 could be omitted with, simply, connectionof end 104 to body 122.

Illustrated in FIG. 6 is another example of an implantable device foranatomical support (device 50). In the drawings, like reference numeralsdenote like components among embodiments. Example device 50 includes ananatomical support member as a suburethral sling 100 with ends 102 and104; interconnecting member 110 with ends 112 and 114; andinterconnecting member 129 with ends 130 and 134. End 112 ofinterconnecting member 110 is coupled to end 1502 of sling 100; and end130 of interconnecting member 129 is fixedly coupled to end 104 of sling100. Although shown in the drawings via phantom lines as being coupledto an underside or bottom surface of sling 100, it is to be understoodthat the coupling of interconnecting members 110 and 129 to sling 100may be provided at any suitable surface of sling 100 and at any suitableorientation thereon.

Fixed anchor 136 includes a body 122 having a proximal end and a distalend, with a longitudinal channel 124 extending therethrough. A pluralityof flanges 126 protruding from the distal end of body 122, separated bywebs 127. End 134 of interconnecting member 129 is fixedly coupled tobody 122 of fixed anchor 136; and fixed anchor 136 includes a collar138. Collar 138 covers the proximal end of body 122 and end 134 ofinterconnecting member 129 coupled to body 122.

Referring to FIGS. 7, 8 and 8A, device 50 also includes an anchor 520and a separate tensioning element 530 slidably coupled tointerconnecting member 110. In one embodiment, anchor 520 includes abody 522 having a channel 526 extending longitudinally therethrough, anda plurality of flanges 524 protruding therefrom separated by webs 527;and in one embodiment, at least one flange 524 has an angled or bevelededge 524E to promote secure placement in obturator tissue OT or otheranatomical tissue.

In one embodiment, at least one web 527 is self-creasing. Specifically,upon application of pressure to flange 524 such as when anchor 520 isbeing deployed through and secured at selected anatomical tissue, web527 tends to fold or crease which thereby tends to facilitate,advantageously, a temporary bending or deflection of an adjacent flange524 downwardly and inwardly toward longitudinal channel 526. In turn,this downward or inward bending or deflection of flange 524 tends tofacilitate such deployment of the anchor through and into the tissue.Furthermore, upon such deployment through tissue, web 527 advantageouslytends to inhibit an inverse bending or deflection of flange 524 upwardlytoward body 522.

Anchor 520 also has a channel 528 through body 522 to permitinterconnecting member 110 to move therethrough in freely slidingengagement with anchor 520. In this example of device 50, and referringto FIGS. 6, 7, and 7A, interconnecting member 110 is partially disposedwithin tensioning element 530. In one embodiment, tensioning element 530is fabricated from a suitable biocompatible material such as, e.g.,silicone or a low durometer thermoplastic material like polyurethane. Inassembly of device 50, ends 112 and 114 of interconnecting member 110are disposed within tensioning element 530 (indicated by paths 532 inFIG. 7). In particular, although not illustrated, it is to be understoodthat in one embodiment end 114 of interconnecting member 110 is driventhrough tensioning element 530 by use of, e.g., a needle. End 114 isthen placed through channel 528 of anchor 520 and then driven by theneedle back through tensioning element 530. As shown in FIG. 7A, byvirtue of exertion of a compressive force and thus frictionalinterference between tensioning element 530 and interconnecting member110, tensioning element 530 is slidably coupled to interconnectingmember 110 to permit bi-directional movement along interconnectingmember 110 upon overcoming such frictional interference. This feature ofsliding frictional interference between interconnecting member 110 andtensioning element 530 permits adjustment and tensioning of sling 100when implanted in a patient. With reference to FIG. 5, it is to beunderstood that device 50 could be substituted for device 10 andimplanted in a pelvic region P of a patient that includes urethra U andobturator tissue OT in each obturator foramen OF. Thus, suburethralsling 100 of device 50 could be positioned under the patient's urethraU, with secure placement of fixed anchor 136 in obturator tissue OT ofone obturator foramen OF and by secure placement of anchor 520 inobturator tissue OT in the other obturator foramen OF. Positions ofanchors 520 and 136 could be exchanged in a left and right senserelative to pelvic region P. By grasping tensioning element 530 andpulling on end 114 away from tensioning element 530 with a forcesufficient to overcome the aforementioned frictional interference forcebetween interconnecting member 110 and tensioning element 530,interconnecting member 110 slides through tensioning element 530 andthus through anchor 520 with a resultant shortening of a distancebetween end 1502 of sling 100 and tensioning element 530. Thereby, sling100 would be raised or elevated under urethra U. Conversely, graspingtensioning element 530 and pulling on end 112 of interconnecting member110 away from tensioning element 530 (or pulling on sling 100 away fromtensioning element 530, or so pulling on both end 112 and sling 100)with such force would overcome the interference and causeinterconnecting member 110 to pass through tensioning element 530 andthus in an opposite direction through tensioning element 530 with aresultant lengthening of a distance between end 1502 of sling 100 andtensioning element 530. Thereby, sling 100 would be lowered underurethra U.

Like device 10, it is to be appreciated and understood that the novelconstruction and operation of device 50 is to be provided with respectto three force parameters. First, device 50 is to be constructed suchthat tensioning element 530 is not destroyed or otherwise damaged uponfrictional sliding movement of interconnecting member 110 through it.Second, device 50 is to be constructed such that neither anchor 136 noranchor 520 are pulled out or dislodged from obturator tissue OT intowhich they have been placed and secured, upon of movement ofinterconnecting member 110 through tensioning element 530 duringintraoperative adjustment. Third, device 50 is to be constructed suchthat the aforementioned interference force between interconnectingmember 110 and tensioning element 530 is sufficiently high to inhibitmovement of sling 100 under urethra U during a provocative event whenthe patient's internal anatomical structures or tissues exert forcesupon device 50.

In one embodiment of device 50, components of anchor 520 could beconstructed in dimensions, and from materials and techniques, asvariously described regarding similar components of fixed anchor 136 indevice 10. Furthermore, components of one embodiment of device 50 couldbe coupled and secured as described relative to similar components ofdevice 10.

Another embodiment of anchor 520 is depicted in FIGS. 9 and 9A whereinchannel 526 is a generally semi-circular or “D” shape. D-shaped channel526, extending longitudinally through body 522, could provide moreclearance for channel 528 compared to the longitudinal and fullycylindrical channel 526 shown in FIGS. 7, 8 and 8A. Furthermore, andalthough not illustrated, longitudinal channel 526 could also beprovided in a smaller diameter than as shown in FIGS. 8A and 9A tothereby provide even greater clearance for channel 528. A path throughchannel 528 is illustrated as being perpendicular to longitudinalchannel 526; but in another embodiment, the path could be at anotherangle relative to channel 526.

It is to be appreciated that when implanted in a patient, sling 100 ofdevices 10 and 50 advantageously extends nearly from obturator tissue OTon one side of the patient to obturator tissue OT on an opposite side ofthe patient as a result of, e.g., an intentionally short segment ofinterconnecting member 129 that couples end 104 of sling 100 to fixedanchor 136 and a selected length of sling 100 with respect to a typicaldistance between opposing obturator foramen OF.

Referring to FIG. 10A, and with additional reference to FIGS. 1, 3, and4, it is to be appreciated that the novel adjustable anchor 120described herein could be useful for secure placement of virtually anyanatomical support member (A) coupled to an interconnecting member 110where it is desired to provide adjustment or tensioning of the supportmember when implanted in a patient. Anatomical support member (A) couldbe, for example, a shaped mesh material for treatment of prolapse. Also,an anatomical support member could employ any number of adjustableanchors 120, with or without any number of fixed anchors 136.

Referring to FIGS. 10B and 10C, it is to be also appreciated that thenovel adjustable anchor 120 described herein could be useful with animplantable device (S) for treatment of urinary incontinence where it isdesired to provide adjustment or tensioning of device (S) when implantedin a patient. Although not specifically depicted in FIGS. 10B-C, it isto be understood however that device (S) could employ any number ofadjustable anchors 120, with or without any number of fixed anchors 136.

Although not illustrated in FIGS. 10A-C, it is to be understood thatanchor 520 with tensioning element 530 could be utilized with anyanatomical support member (A); and any number of combinations of anchor520 with tensioning element 530 could also be utilized with or withoutany number of fixed anchors 136.

Regardless of a particular embodiment of adjustable anchor 120, or ofanchor 520 with tensioning element 530, it is to be understood andappreciated that such novel anchors described herein may be relativelysmall when compared to known anatomical anchors. This advantage resultsfrom the fact that the novel anchors described herein are coupled toanatomical support members by sutures or suture-like filaments, ratherthan directly to the anatomical support members themselves which areusually larger and wider than sutures or suture-like filaments as insome known anatomical anchors. In alternative embodiments, any of theanchors (e.g., anchors 120, 136, or 520) would include at least oneflange 126.

FIGS. 11 and 12 illustrate an example of a tool for use in placing animplantable device for anatomical support in a patient, such as sling100 of FIG. 1. In the drawing, a pair of tools 600R and 600L areillustrated, in left hand and right hand embodiments—with suchdesignations referring to a patient's left and right sides,respectively. It is to be understood that the tools are identical exceptfor a direction of a helical curve C as described below.

In this example, tools 600R and 600L each include a shaft 610 having aproximal end 612 and a cylindrical distal tip 618. A handle 620 iscoupled to proximal end 612 of shaft 610. Handle 620 could have anydesired shape or configuration with respect to ergonomic and otherconsiderations of interest. A generally helical curve C is provided inshaft 610. Helical curve C terminates in a shoulder 616 proximate todistal tip 618. In use as described below, helical curve C isadvantageously configured to guide tip 618 from an incision (e.g., avaginal incision in a female patient or a perineal incision in a malepatient), around a descending ramus, and through an obturator foramen OFin the patient. In this example, and as shown in FIG. 12, cylindricaldistal tip 618 is configured to be placed through cylindrical channels124 of adjustable anchor 120 and fixed anchor 136 (as shown in, e.g., inFIGS. 2 and 3), and through cylindrical channel 526 of anchor 520 (asshown, e.g., in FIGS. 7, 8, and 8A). When so placed, shoulder 616 abutsthe anchor's body adjacent to the flanges with the anchor being therebycarried on tip 618 of tool 600R or 600L. Although not illustrated, it isto be understood that if an anchor was constructed with a semi-circularor “D” shaped channel 526 as depicted in FIGS. 9 and 9A, tip 618 wouldthen be a complementary semi-circular or “D” shaped configuration.

In one embodiment, handle 620 has a length of 11.43 cm (4.5 in.). Alength of shaft 610, from handle 620 to a beginning point 614 of curve Cis 17.78 cm (7.0 in.). Shaft 610 has a diameter of 3 mm (0.12 in.)decreasing to 1 mm (0.04 in.) at shoulder portion 616. Curve C has aradius of curvature in a range of 2.03 cm (0.80 in.) to 2.54 cm (1.0in.). Suitable materials for construction of handle 620 include, forexample, a medical grade thermoplastic or thermoset material, preferablyhaving both high and low durometer regions for ergonomic considerations.A suitable material for construction of shaft 610 is, for example,medical grade stainless steel. Furthermore, the tool describedherein—such as the examples of tools 600R and 600L—could be disposableor sterilizable and reusable.

It is to be appreciated that in one embodiment, as shown particularly inFIG. 12, a length of distal tip 618 is chosen so that it protrudes froman anchor seated on shoulder 616. When constructed from stainless steelas aforementioned, relatively stiff tip 618 is thereby configured topierce anatomical tissue when in use as described below. Thereby, theanchor itself does not need to include such a tissue-penetrating tip.

Referring in particular to FIGS. 1, 5, 11, and 12, an example of asurgical method to implant a device for anatomical support 10, in a formof suburethral sling 100 for treatment of urinary incontinence in afemale patient, is as follows.

A catheter is placed in the patient's urethra U, among other usual andpreliminary steps in preparation for surgery. The patient is placed onan operating table in a slightly exaggerated lithotomy position withbuttocks extending just beyond an edge of the table. With the patientunder anesthesia, a vaginal incision and blunt dissection are made. Inone embodiment of the method, a fixed anchor is first placed inobturator tissue OT on the patient's left side, followed by placement ofan adjustable anchor in obturator tissue OT on the patient's right side.Accordingly in this embodiment, fixed anchor 136 is placed on distal tip618 of left hand tool 600L having an orientation of helical curve Ccorresponding to the patient's left side. Tip 618 of left hand tool600L, with fixed anchor 136 seated thereupon, is placed within thevaginal incision. Left hand tool 600L is then rotated such that rotationof helical curve C advances tip 618 and fixed anchor 136 in a patharound a descending pubic ramus (PR) on the patient's left side,continuing in that path until fixed anchor 136 penetrates obturatortissue OT on the patient's left side (as may be indicated by an audibleor tactile “pop”) and is thus secured therein. By virtue of flanges 126,fixed anchor 136 is inhibited from being pulled back through obturatortissue OT so penetrated as shown in FIG. 5. Left hand tool 600L is thenremoved from the patient. Next in this embodiment, adjustable anchor 120is placed on distal tip 618 of right hand tool 600R having anorientation of helical curve C corresponding to the patient's rightside. Tip 618 of right hand tool 600R, with adjustable anchor 120 seatedthereupon, is placed within the vaginal incision. Right hand tool 600Ris then rotated such that rotation of helical curve C advances tip 618and adjustable anchor 120 in a path around a descending pubic ramus (PR)on the patient's right side, continuing in that path until adjustableanchor 120 penetrates obturator tissue OT on the patient's right side(as may be indicated by an audible or tactile “pop”) and is thus securedtherein. By virtue of flanges 126, adjustable anchor 120 is inhibitedfrom being pulled back through obturator tissue OT so penetrated asshown in FIG. 5. Right hand tool 600R is then removed from the patient.

With suburethral sling 100 thus placed and secured in the patient by wayof fixed anchor 136 and adjustable anchor 120, an assessment is made ofwhether sling 100 is unacceptably loose or tight under urethra U. Ifsling 100 is unacceptably loose, then end 114 of interconnecting member110 is pulled away from adjustable anchor 120 with a force sufficient toovercome the aforementioned interference force between interconnectingmember 110 and adjustable anchor 120. Interconnecting member 110 thuspasses through anchor 120 with a resultant shortening of a distancebetween end 1502 of sling 100 and adjustable anchor 120. Thereby sling100 is raised or elevated under urethra U as desired. Conversely, ifsling 100 is unacceptably tight, then end 112 of interconnecting member110 is pulled away from adjustable anchor 120 (or sling 100 is pulledaway from adjustable anchor 120, or both end 112 and sling 100 are sopulled) with a force sufficient to overcome the interference forcebetween interconnecting member 110 and adjustable anchor 120.Interconnecting member 110 thus passes through anchor 120 with aresultant lengthening of a distance between end 1502 of sling 100 andadjustable anchor 120. Thereby sling 100 is lowered under urethra U asdesired. These steps of shortening and lengthening a distance betweenend 1502 of sling 100 and adjustable anchor 120 may be repeated in anyorder and as frequently as necessary to provide optimal suburethralsupport from sling 100 to urethra U. The vaginal incision is then closedand usual post-operative procedures are performed.

In another embodiment, the aforedescribed method could employ an exampleof device 50 as shown in FIGS. 6-8A. In this embodiment of the method, acatheter is placed in the patient's urethra U and the aforementionedpreliminary steps in preparation for surgery are performed. The patientis placed in a slightly exaggerated lithotomy position with buttocksextending just beyond an edge of an operating table; and underanesthesia, a vaginal incision and blunt dissection are made in thepatient. In one embodiment of this method using device 50, a fixedanchor is first placed in obturator tissue OT on the patient's leftside, followed by placement of an anchor in obturator tissue OT on thepatient's right side that is associated with a separate tensioningelement. Accordingly, fixed anchor 136 is placed on distal tip 618 ofleft hand tool 600L having an orientation of helical curve Ccorresponding to the patient's left side. Tip 618 of left hand tool600L, with fixed anchor 136 seated thereupon, is placed within thevaginal incision. Left hand tool 600L is then rotated such that rotationof helical curve C advances tip 618 and fixed anchor 136 in a patharound a descending pubic ramus (PR) on the patient's left side,continuing in that path until fixed anchor 136 penetrates obturatortissue OT on the patient's left side (as may be indicated by an audibleor tactile “pop”) and is thus secured therein. By virtue of flanges 126,fixed anchor 136 is inhibited from being pulled back through obturatortissue OT so penetrated as shown in FIG. 5. Left hand tool 600L is thenremoved from the patient. Next in this embodiment using device 50,anchor 520 is placed on distal tip 618 of right hand tool 600R having anorientation of helical curve C corresponding to the patient's rightside. Tip 618 of right hand tool 600R, with anchor 520 seated thereupon,is placed within the vaginal incision. Right hand tool 600R is thenrotated such that rotation of helical curve C advances tip 618 andanchor 520 in a path around a descending pubic ramus (PR) on thepatient's right side, continuing in that path until anchor 520penetrates obturator tissue OT on the patient's right side (as may beindicated by an audible or tactile “pop”) and is thus secured therein.By virtue of flanges 126, anchor 520 is inhibited from being pulled backthrough obturator tissue OT so penetrated. Right hand tool 600R is thenremoved from the patient.

With suburethral sling 100 of device 50 thus placed and secured in thepatient by way of fixed anchor 136 and anchor 520, an assessment is madeof whether sling 100 is unacceptably loose or tight under urethra U. Ifsling 100 is unacceptably loose, then tensioning element 530 is graspedand end 114 of interconnecting member 110 is pulled away from tensioningelement 530 with a force sufficient to overcome the aforementionedinterference force between interconnecting member 110 and tensioningelement 530. Interconnecting member 110 thus passes through anchor 520with a resultant shortening of a distance between end 1502 of sling 100and tensioning element 530. Thereby sling 100 is raised or elevatedunder urethra U as desired. Conversely, if sling 100 is unacceptablytight, then tensioning element 530 is grasped and end 112 ofinterconnecting member 110 is pulled away from tensioning element 530(or sling 100 is pulled away from tensioning element 530, or both end112 and sling 100 are so pulled) with a force sufficient to overcome theinterference force between interconnecting member 110 and tensioningelement 530. Interconnecting member 110 thus passes through anchor 120with a resultant lengthening of a distance between end 1502 of sling 100and tensioning element 530. Thereby sling 100 is lowered under urethra Uas desired. Similarly to device 10, these steps of shortening andlengthening a distance between end 1502 of sling 100 and tensioningelement 530 in device 50 may be repeated in any order and as frequentlyas necessary to provide optimal suburethral support from sling 100 tourethra U. The vaginal incision is then closed and usual post-operativeprocedures are performed.

The adjustable anchor 120 and/or the fixed anchor 136 are each suitedfor attachment to support devices having a variety of shapes, includingthe rectangular shapes described and illustrated above, non-rectangularshapes described and illustrated below, or other symmetrical ornon-symmetrical shapes as appropriate for providing anatomical support.

FIG. 13 is a top view of one embodiment of an implantable anatomicalsupport 700 device. The implantable anatomical support 700 includes asupport body 702 with at least three arms 704 extending from the supportbody 702, an interconnecting member 110 that is coupled to each of thearms 704 extending from the support body 702, and an adjustable anchor120 slidably coupled to each of at least two of the interconnectingmembers 110.

The adjustable anchors 120 are configured for bi-directional movementalong the interconnecting member 110 and exert a compressive forcegenerating frictional interference between the adjustable anchor 120 andthe interconnecting member 110. The frictional interference between theadjustable anchor 120 and the interconnecting member 110 inhibits thebi-directional movement of the adjustable anchor 120 along theinterconnecting member 110 unless sufficient force is applied toovercome the frictional interference.

The arms 704 in combination with the interconnecting members 110 and theadjustable anchors 120 allow the anatomical support 700 to be implantedin a body and adjusted into a desired tensioned position. Theinterconnecting members 110 and the adjustable anchors 120 obviate theuse of multiple skin exit punctures, and eliminate the use of retrievercomponents and sleeves around the arms 704 that are at times employedwith support bodies having arms.

The support body 702 is non-rectangular and the support 700 includesfour arms 704 extending from the non-rectangular support body 702. Inone embodiment, the support body 702 has a curved outside perimeter withbilateral symmetry relative to a central longitudinal axis of thenon-rectangular support body 702. In one embodiment, the support body702 has four arms 704 and includes a central tail 706 located betweentwo of the arms 704. The central tail is configured for attachment to asuitable pelvic landmark, such as a ligament or other tissue. In oneembodiment, the support body 702 is fabricated from a porous meshconfigured to be compatible with biological in-situ tissue ingrowth.

In one embodiment, the arms 704 include a first arm segment 710extending from support body 702 and a second arm segment 712 extendingfrom the first arm segment 710, where the interconnecting members 110extend from the second arm segment 712.

In one embodiment, the second arm segment 712 is the removed end portion1504 of the sling 100 described above and is attached to body 702. Inone embodiment, the second arm segment 712 is fabricated from theknitted polypropylene material described above and is attached to thefirst arm segment 710 and the support body 702. In one embodiment, thefirst arm segment 710 is fabricated from a different material than thesecond arm segment 712. Suitable attachment methods for attaching thesecond arm segment 712 to the first arm segment 710 include adhesiveattachment, mechanical attachment devices such as clips, and energeticattachments such as sonic or ultrasonic welds, as examples.

In one embodiment, the first arm segment 710 is fabricated from the samematerial as the second arm segment 712. For example, each of the firstarm segment 710 and the second arm segment 712 is fabricated fromknitted polypropylene ARIS® brand mesh material that is commerciallyavailable from Coloplast A/S.

In one embodiment, the first arm segments 710 extend 1 cm or more fromthe support body 702. In one embodiment, one or more of the first armsegments 710 is provided as a “stubby” arm segment that extends from thesupport body 702 by less than 1 cm, for example. The second arm segment712 extends from the first arm segment 710 (whether of the “stubby”format or not). The interconnecting member 110 is attached to the secondarm segment 712, and one or the other of the adjustable anchor 120 orthe fixed anchor 136 is attached to the interconnecting member 110.

In one embodiment, an interconnecting member 110 is attached to each arm704 and an adjustable anchor 120 is attached to each interconnectingmember 110. In one embodiment, an interconnecting member 110 is attachedto each arm 704 and a fixed anchor 136 (FIG. 1) is attached to at leastone of the interconnecting members 110. It will be recognized that theimplantable anatomical support 700 could include one or more adjustableanchors with anywhere from zero to one or more fixed anchors. It is tobe appreciated, then, that the device 700 could employ any number ofadjustable anchors 120, with or without any number of fixed anchors 136.

FIG. 14 is a top view of one embodiment of an implantable anatomicalsupport 800. The implantable anatomical support 800 includes a supportbody 802 with at least three arms 804 extending from the support body802, an interconnecting member 110 that is coupled to the arms 804extending from the support body 802, and an adjustable anchor 120slidably coupled to each of at least two of the interconnecting members110.

The adjustable anchors 120 are configured for bi-directional movementalong the interconnecting member 110 and exert a compressive forcegenerating frictional interference between the adjustable anchor 120 andthe interconnecting member 110. The frictional interference between theadjustable anchor 120 and the interconnecting member 110 inhibits thebi-directional movement of the adjustable anchor 120 along theinterconnecting member 110 unless sufficient force is applied toovercome the frictional interference.

The arms 804 in combination with the interconnecting members 110 and theadjustable anchors 120 allow the anatomical support 800 to be implantedin a body and adjusted into a desired tensioned position. Theinterconnecting members 110 and the adjustable anchors 120 obviate theuse of multiple skin exit puncture, and eliminate the use of retrievercomponents and sleeves around the arms 804 that are at times employedwith support bodies having arms.

The support body 802 is non-rectangular and the support 800 includes twoarms 804 a, 804 b extending from one side of the non-rectangular supportbody 802 and a third arm 804 c that is provided opposite the two arms804 a, 804 b. In one embodiment, the support body 802 has a curvedoutside perimeter with bilateral symmetry relative to a centrallongitudinal axis of the non-rectangular support body 802. In oneembodiment, the support body 802 has three arms 804, with aninterconnecting member 110 attached to one each of the two arms 804 a,804 b with the third arm 804 c configured for direct attachment to bodytissue, for example via sutures. In one embodiment, the support body 802is fabricated from a porous mesh configured to be compatible withbiological in-situ tissue ingrowth.

In one embodiment, the arms 804 a, 804 b are provided with a first armsegment 810 extending from support body 802 and a second arm segment 812extending from the first arm segment 810, where the interconnectingmembers 110 extend from the second arm segment 812.

FIG. 15 is a top view of one embodiment of an implantable anatomicalsupport 900. The implantable anatomical support 900 is similar to theimplantable anatomical support 800 and includes the support body 802with the arms 804 extending from the support body 802, with oneadjustable anchor 120 slidably coupled to one interconnecting member 110and a fixed anchor 136 connected to another interconnecting members 110.During implantation, the surgeon selectively attaches the fixed anchor136 to appropriately identified tissue, attaches the adjustable anchorto adjacent tissue, and adjusts the adjustable anchor 120 along theinterconnection member 110 to suitably adjust the tension in the support900.

Although not illustrated in FIGS. 13-14, it is to be understood thatanchor 520 with tensioning element 530 (FIG. 6) could be utilized withanatomical support 700 and any number of combinations of anchor 520 withtensioning element 530 could also be utilized with or without any numberof fixed anchors 136.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

FIG. 16 is a top view of one embodiment of a system 1000 configured toaddress pelvic dysfunction in a patient. Pelvic dysfunction includesmale urinary incontinence, female urinary incontinence, or female pelvicorgan prolapse.

In one embodiment, the system 1000 is configured to address male urinaryincontinence and includes a support member 1002 and a tool 1004configured to couple with the anchors 120, 136 to implant the supportmember 1002 into the patient, for example via a single incision.

In one embodiment, the support member 1002 includes a body portion 1010,and opposing trans obturator arms 1012 and suprapubic arms 1014extending from the body portion 1010. In one embodiment, the fixedanchor 136 is attached to one of the trans obturator arms 1012 by theinterconnecting member 129 and the adjustable anchor 120 is attached tothe opposing one of the obturator arms 1012 by the interconnectingmember 110.

As described below, the tool 1004 is employed to attach/anchor theanchors 120, 136 into membrane material of the obturator foramen suchthat the obturator arms 1012 extend between the opposing obturatormembranes. The suprapubic arms 1014 are surgically placed suprapubically(with or without a tool).

In one embodiment, the anchor 120 is an adjustable anchor as describedabove and the support member 1002 includes four arms that are configuredfor four-point attachment to the patient to provide an adjustablesupport offering elevation and compression of the ventral urethral bulbof a man with compression of the perineal urethra. The support member1002, as implanted, is configured to provide immediate beneficial reliefto urinary incontinence and is also configured to allow tissue to growinto the porous structure of the support member 1002.

FIG. 17 is a top view of the support member 1002 modified to includeoptional suture lines 1015 connected to a removable tip 1017 at an endof each of the suprapubic arms 1014 and optional sleeves 1016 disposedover the arms 1014. The optional suture lines 1015 and sleeves 1016 areemployed when placing the arms 1014 suprapubically within the patientwith the tool 1004.

In general, the trans obturator arms 1012 are provided as a pair ofopposing and aligned arms and the suprapubic arms 1014 are not parallelwith the trans obturator arms 1012. Other conformations for supportmember 1002 are also acceptable, including more than four arms or fewerthan four arms, and the relative orientation between the arms providedin the examples is not intended to limit the scope of this application.

In one embodiment, the support member 1002 is fabricated from a porouspolypropylene mesh suited to allow tissue to grow into the mesh. In oneembodiment, the support member 1002 includes optional sleeves 1016disposed over the suprapubic arms 1014, for example, where the sleeves1016 reduce friction of the arms 1014 as they are implanted withintissue of the patient. In one embodiment, the optional suture lines 1015are braided polyester lines that are coated with a friction-reducingagent such as polytetrafluoroethylene, although other forms of suturelines and other forms of friction-reducing agents are also acceptable.

FIG. 18A is a top view of the tool 1004 and FIG. 18B is a close-up viewof a distal end portion 1026 of the tool 1004.

In one embodiment, the tool 1004 includes a hook 1020 extending from ahandle 1022 between a proximal end 15024 and a distal end portion 1026.The hook 1020 is a planar hook having a curve and is configured for aninside-out pass from a midline incision in the patient through amembrane tissue covering the obturator foramen. In one embodiment, thehook 1020 is formed of a suitable material, for example stainless steel,fashioned to lie in a plane (i.e., the hook 1020 is a “planar” hook)between the end 15024 and the distal end portion 1026. The illustratedembodiment of the hook 1020 in FIG. 18A is not a helical hook.

In one embodiment, the hook 1020 is a substantially solid hook (i.e.,the hook does not include a lumen) having a curved section 1027connected between a first linear section 1028 and a second linearsection 1029. The curvature of the curved section 1027 is not constantas the curved section 1027 has greater curvature adjacent the secondlinear section 1029 as compared to the first linear section 1028. Thesecond linear section 1029 is not parallel to the first linear section1028, and a ray extending from and aligned with the second linearsection will intersect a horizontal plane from which the proximal end15024 of the hook 1020 extends.

The hook 1020/tool 1004 is configured to implant the support member 1002into a male patient via an inside-out pass extending from a singleperineal incision to an obturator foramen of the male patient, where thepass minimizes the possibility of undesirably perforating the urethra orthe corpus cavernosa of the patient.

In one embodiment, the distal end portion 1026 of the hook 1020 (FIG.18B) includes a distal end 1030, an L-shaped slot 1032 proximal thedistal end 1030, and a T-shaped slot 1034 proximal the L-shaped slot.The hook 1020 is preferably formed from a stable material such asstainless steel and the handle 1022 is preferably formed from plastic,for example, although other materials are also acceptable.

FIG. 19 is a schematic view of a pelvis P of a patient having a pair ofobturator foramen OF. The pelvis P is surgically accessed through asingle, minimally invasive perineal incision 1040. A reference axis 1042is provided that is aligned on a midline of the patient's body from theincision 1040 through the pubic symphysis. The reference axis 1042separates the patient's body between the left side of the patient andthe right side of the patient (e.g., the right side includes theillustrated obturator foramen OF).

The support member 1002 (FIG. 17) is implanted, for example, by formingthe perineal incision 1040 and dissecting to isolate the bulbous urethra(for men) while ensuring that the bulbous spongiosis muscle remainsintact. The surgeon will optionally, depending upon surgeon preference,dissect down to the pubic ramus to identify this landmark.

With reference to FIGS. 17 and 18B, the surgeon forms the perinealincision 1040 and employs the tool 1004 to guide each of the transobturator arms 1012 along an inside-out path through the obturatorforamen. For example, a distal end 1030 of the hook 1020 is engaged withthe fixed anchor 136. The hook 1020 and the fixed anchor 136 areinserted into the perineal incision 1040, guided along an inside-outpath that extends inward to a descending portion of the ramus of thepatient, and into the membrane extending over the obturator foramen OF.The distal end 1030 of the hook 1020 penetrates the membrane extendingover the obturator foramen OF with an audible “pop,” indicating thefixed anchor 136 is attached to the membrane of the obturator foramenOF. In a similar maneuver, the distal end 1030 of the hook 1020 isengaged with the adjustable anchor 120, and the hook 1020 and adjustableanchor 120 are inserted into the perineal incision 1040, along acontra-lateral inside-out path to a descending portion of the ramus ofthe patient and into the membrane extending over the obturator foramenOF. Once again, when the distal end 1030 of the hook 1020 penetrates theforamen membrane an audible “pop” indicates a successful anchoring ofthe adjustable anchor 120 into the membrane of the obturator foramen.

In one embodiment, the suprapubic arms 1014 (having the optional sleeves1016 of FIG. 17 removed) are inserted into the single perineal incision1040 and tunneled into position subcutaneously within the patient. Forexample, the tool 1004 (or another suitable tool) is employed to insertthe suprapubic arms 1014 into the incision 1040 suprapubically, at whichlocation the arms 1014 are overlapped subcutaneously within the patientto allow tissue ingrowth to secure the support member 1002 within thepatient.

With reference to FIGS. 17 and 20, in one embodiment the suprapubic arms1014 (including the optional sleeves 1016 of FIG. 17) are implanted bythe tool 1004 subcutaneously within the patient via a pre-pubic opening.For example, the distal end 1030 of the hook 1020 is inserted under thepatient's skin and moved subcutaneously from the pre-pubic opening tothe perineal incision 1040 lateral the urethra. One of the suprapubicarms 1014 is attached to the T-shaped slot 1034 and retracted backwardsby the tool 1004 along the path from the perineal incision 1040 to thepre-pubic opening. The other suprapubic arm 1014 is implantedcontra-laterally in a similar manner. Afterwards, the suture, the tipand the optional sleeves 1016 are removed from the suprapubic arms 1014leaving the porous mesh in place for subsequent tissue ingrowth. In oneembodiment, excess length of the suprapubic arms 1014 is trimmed flushwith the patient's skin. In one embodiment, the suprapubic arms 1014 arecrossed/overlapped one over the other subcutaneously.

The trans obturator arms 1012 are suspended/connected in a midlinelocation between the membrane of the obturator foramen OF and thesuprapubic arms 1014 are retained in a fixed position subcutaneously. Inone embodiment, the interconnecting member 110 is pulled through theadjustable anchor 120 shorten the midline length between the ends of thetrans obturator arms 1012 and adjust tension in the support member 1002.In this manner, support member 1002 elevates and compresses the ventralurethral bulb B of the patient. The suprapubic arms 1014 are pulled toadjust tension prior to being secured to each other, which compressesthe perineal urethra U. The support member 1002 allows the surgeon totighten or loosen the tension between the arms 1012 by adjusting theadjustable anchor 120.

FIG. 21 is a schematic view of the support member 1002 implanted in amale patient. The illustration presents a sub-dermal view of thelocation of the support member 1002 relative to the ventral urethralbulb B of the patient. The trans obturator arms 1012 extend betweenmembranes covering the obturator foramen OF and are adjustable via theadjustable anchor 120 to elevate and compress the ventral urethral bulbB of the patient. The suprapubic arms 1014 are tunneled subcutaneouslyto compress the perineal urethra U. The surgeon adjusts thetension/elevation of the support member 1002 by drawing theinterconnecting member 110 through the adjustable anchor and adjusts thecompression of the support member 1002 against the ventral urethral bulbB of the patient by selectively tightening the suprapubic arms 1014.This adjustment of the two pairs of arms 1012, 1014 may be doneincrementally until the surgeon achieves the desired coaptation of theurethra U through the elevation and compression of the ventral urethralbulb B of the patient.

The implanted arms 1012, 1014 and the body portion 1010 allow tissueingrowth through the support member 1002, which tends to provide a moredurable and long-lasting support to address male incontinence.

The above-described approach to addressing urinary incontinence is lessinvasive than implanting an artificial urinary sphincter (artificialurinary sphincters can contribute to erosion of the urethra), which aidsthe patient to a faster recovery, and has the potential for immediatepost-implantation beneficial continence results.

The adjustable anchor 120 of the support member 1002 is movable alongthe interconnecting member 110 to adjust the elevation of a mid-area(identified as supporting the bulbous urethra B) of the support 1002relative to a urethra of the patient.

The elevation and compression of the urethra bulb provides VentralUrethral Elevation (VUE) that ensures consistent placement of thesupport with a decreased probability of loosening. The minimaldissection of the bulbous urethra minimizes the potential for distalmovement of the support member 1002. Support member 1002 is implantedthrough a single perineal incision 1040 that is less invasive than othersurgical interventions for remedying male incontinence.

FIG. 22A is a perspective view of one embodiment of a support member1100 including adjustable anchor 120 and a hanger 1102. In oneembodiment, the support member 1100 is a substantially rectangularporous mesh termed a “tape,” substantially as illustrated in FIG. 22A,and fabricated from materials similar to those described above for thesling 100 (FIG. 1). The support member 1100 is configured forimplantation into a male patient or a female patient via a singlemidline incision (perineal for men and paraurethral or vaginal forwomen) and includes a mechanism for adjusting tension in the support1100.

The adjustable anchor 120 described above is attached to the first end1502 of the support member 1100 by the interconnecting member 110, and ahanger 1102 is attached to the second end 104 of the support member. Inone embodiment, the hanger 1102 is fabricated from plastic and isattached to the end 104 of the support 1100 by welding, stitching,adhesive attachment, or another suitable form of attachment.

The hanger 1102 is configured to hang over a portion of a pubic ramus ofa pelvis to secure a second end 104 of the support member 1100, and theadjustable anchor 120 is attachable to a membrane extending over anobturator foramen. The interconnecting member 110 slides relative to theanchor 120 to adjust the tension and support provided by the supportmember 1100. The hanger 1102 is configured to be placed over a surfaceof the pubic bone without the use of screws. In this manner, the hanger1102 does not penetrate the bone, which allows the surgeon to morequickly and accurately place the support 1100 inside the patient.

FIG. 22B is a side view and FIG. 22C is a front view of the hanger 1102.In one embodiment, the hanger 1102 extends between a proximal end 1110and a distal end 1112, and includes a curved hanging portion 1114. Theproximal end 1110 is attached to the end 104 of the support 1100 (FIG.22A). In one embodiment, the distal end 1112 converges to a point thatis configured to penetrate the obturator foramen membrane and allow thehanging portion 1114 to engage with and drape over a pubic ramus. Thehanging portion 1114 is curved to correspond to a curvature of the pubicramus bone of the pelvis.

FIG. 23 is a schematic view of the support member 1100 attached betweena pubic ramus PR of the pelvis P and tissue OT of the obturator foramenOF to support a urethra U of the patient. In one embodiment, the patientis a female and the support member 1100 supports the urethra U withoutcompressing the urethra U. In one embodiment, the patient is a male andthe support member 1100 supports the urethra U by elevating andcompressing at least a portion of a bulb the urethra U.

It is to be understood that it is undesirable to dissect tissue awayfrom and expose the urethra U (which can contribute to urethralerosion). The illustration of the figures shows a urethra U with athickness to indicate tissue is still surrounding the urethra.

In one embodiment, the hanger 1102 is introduced through a singleperineal incision 1140 along an inside out pass that places the hanger1102 around a portion of the pubic ramus PR. For example, the surgeonplaces the hanger 1102 either digitally with a finger, or with a tool,into the incision 1140 and guides the hanger 1102 inward against themembrane covering the obturator foramen, after which the surgeonpenetrates the membrane with the pointed distal end 1112 (FIG. 22C) ofthe hanger 1102. Movement of the pointed distal end 1112 of the hanger1102 through the obturator foramen membrane positions the hangingportion 1114 for engagement over the pubic ramus PR.

The adjustable anchor 120 is guided through the incision 1140 with thetool 1004 (FIG. 18A) as described above in FIG. 19. The tension of thesupport member 1100 is adjusted by pulling on the interconnecting member110 until a desired length of the support member 1100 is achieved thatprovides support to the tissue around the urethra U, as described above.In this manner, the adjustable anchor 120 of the support 1100 allows theelevation of mid-area of the support 1100 under the urethra to beadjusted to support the urethra without displacing or compressing theurethra (as desirable in a female). The surgeon closes the minimallyinvasive single incision 1140 according to acceptable practices. Thesupport provides the patient with a state of continence immediatelyafter implantation due to the support or support and elevation of theurethra U.

FIG. 24 is a top view of one embodiment of a support member 1200including adjustable anchors 120 and adjustable hangers 1102 that allowthe support 1200 to be implantable via a single incision. The supportmember 1200 is similar to the support member 1002 (FIG. 17) and includesthe body portion 1010, and opposing trans obturator arms 1012 andsuprapubic arms 1014 extending from the body portion 1010.

In one embodiment, an adjustable anchor 120 is attached to each of theopposing trans obturator arms 1012 by an interconnecting member 110, andthe adjustable hanger 1102 is attached to each of the suprapubic arms1014 by an adjustable suture 1202. The adjustable suture 1202 isconfigured to allow the independent adjustment of the distance betweeneach hanger 1102 and the arm 1014 to which it is attached in a mannersimilar to that described above in FIGS. 2-4, for example. For example,the adjustable hanger 1102 is movable distally and proximally along thesuture line 1202 to allow for the selected and independent adjustment ofthe hanger 1102 relative to the support 1200. The support member 1200 isconfigured for implantation into the patient via a single incision, andas such, the optional sleeves 1016 (FIG. 17) covering one or more of thearms are not provided on the support member 1200.

The support member 1200 is fabricated from the materials describedabove, and in one embodiment is provided as a porous polypropylene meshhaving a pore size of about 665 micrometers, a porous area of about42.3% of the total area, a basis weight of about 119 g/m², and athinness of about 635 micrometers.

The adjustable anchors 120 and hangers 1102 are as described above. Itis to be understood that the support 1200 could be provided with fouradjustable anchors 120 or four adjustable hangers 1102, or combinationsof adjustable anchors and hangers. During implantation, the surgeonselectively and independently adjusts each anchor 120 and each hanger1102 by sliding the adjustable component along its respective line 110,1202 to achieve the desired amount of support or elevation orcompression of the implanted support 1200 relative to the patient'sanatomy.

FIG. 25 is a schematic view of one embodiment of the support member 1200having the adjustable anchors 120 attached to membranes of obturatorforamen OF and the hangers thousand 102 secured to the pelvis P.

In one embodiment, support member 1200 is implanted into the pelvis ofthe patient through a single midline incision 1240. In a male example,the adjustable anchors 120 are implanted through a perineal incision ofa man and attached to the membrane tissue OT extending over theobturator foramen OF by the tool 1004 (FIG. 16) via the approachdescribed above. In a female example, the adjustable anchors 120 areimplanted through a vaginal incision of a woman and attached to themembrane tissue OT extending over the obturator foramen OF by the tool1004 (FIG. 16) via the approach described above.

In particular, one of the adjustable anchors 120 is attached to thedistal end 1030 of the tool 1004, the distal end 1030 and the adjustableanchor 120 are inserted through the incision 1240 and guided to alocation superior the pubic ramus PR where the tool 1004 forces theadjustable anchor 120 into the membrane OT of the obturator foramen OFto attach one of the trans obturator arms 1012 to the patient. A similarmaneuver is carried out on the contra-lateral side of the patient toimplant the other of the trans obturator arms 1012.

In one embodiment, suprapubic arms 1014 are each inserted individuallyand guided suprapubically and subcutaneously to a prominence of thepelvis P over which the anchors 1102 are hung. The suture line 1202 isadjusted to place the arm 1014 in the desired location. Alternatively, atool or other device is employed to guide the hangers 1102subcutaneously to the pelvis P.

The anchors 120 are adjusted to support to the urethra U by sliding one(or both) of the interconnecting members 110 through a respective one ofthe adjustable anchor 120 after implantation of the support member 1200in the manner described above. In this manner, tension provided by thesupport member 1200 relative to the urethra U is adjustable by thesurgeon to achieve compression and elevation of the urethra U in a manor support without compression of the urethra in a woman. Each of theadjustable anchors 120 is individually adjustable to allow the urethra Uto be centered relative to the trans obturator arms 1012.

FIG. 26 is a schematic view of a pair of adjustable slings 100 asillustrated in FIG. 1 implanted into a patient via a single incision1140 to alleviate pelvic dysfunction.

In one embodiment, two or more slings 100 are implanted into a malepatient through a single minimally invasive perineal incision 1140 (forexample with tool 1004) and held in place by anchors 120, 136. Theadjustable anchor 120 permits each sling 100 to be adjusted. Inaddition, each sling 100 is configured to be selectively positioned bythe surgeon to provide elevation and compression of the urethral bulbaround the urethra U of a male patient.

In one embodiment, two or more slings 100 are implanted into a femalepatient through a single minimally invasive vaginal incision 1140(again, with the tool 1004) and held in place by the anchors 120, 136.The adjustable anchor 120 permits each sling 100 to be adjusted. Thesurgeon may selectively position each sling 100 to provide support forthe urethra of the female without compression of the urethra, which canundesirably erode the short female urethra.

By the embodiments described above, adjustable slings and supports areprovided that are configured to be implanted into the patient (male orfemale) through one minimally invasive single incision. The adjustablesupport provides an immediate remedy to the incontinence of the patientbecause of the tensioned and adjustable arms in combination with therapid healing of the minimally invasive procedure.

It is to be again appreciated that components of these devices could bereversed, if desired, in a right side/left side sense from theirarrangements as shown in the examples of FIGS. 1 and 5. It is also to beappreciated that method steps could be performed in other sequences.

It is also to be appreciated that the examples of methods describedherein, for surgical placement of devices for anatomical support, do notrequire skin exits or incisions other than for a single vaginal incision(or, in a male patient, a single perineal incision) for placement andadjustment.

Upon occurrence of tissue in-growth, after implantation surgery iscompleted and during the patient's healing process, anchors might thenbecome unnecessary to continue to secure the anatomical support devicein the patient. Therefore, any of the anchors and the interconnectingmembers could be made of a suitable medical grade bioresorbablematerial.

It is to be also appreciated that the foregoing examples of implantabledevices for anatomical support provide means for adjustment ortensioning of anatomical support members that are not dependent uponanchor placement. For example, increased tensioning of the devices maybe advantageously achieved without a need for advancing anchors moredeeply into target tissue in the patient. Also, the aforedescribedfrictional sliding engagement between interconnecting member 110 andadjustable anchor 120—or between interconnecting member 110 andtensioning element 530—permits novel intra-operative adjustment of theimplantable devices for anatomical support disclosed herein. Furthermoreadjustable anchor 120, as well as the combination of anchor 520 withtensioning element 530, permits such intra-operative adjustment to beperformed as many times as desired during a particular implantationprocedure, to achieve optimal device placement, adjustment, andtensioning.

While implantable devices, tools, and methods for anatomical supporthave been particularly shown and described herein with reference to theaccompanying specification and drawings, it will be understood howeverthat other modifications thereto are of course possible; and all ofwhich are intended to be within the true spirit and scope of the claimedinvention. It should be appreciated that (i) components, dimensions,shapes, and other particulars of the example embodiments herein may besubstituted for others that are suitable for achieving desired results,(ii) various additions or deletions may be made thereto, and (iii)features of the foregoing examples may also be made in combinationsthereof. It is also to be understood in general that any suitablealternatives may be employed to provide these implantable devices,tools, and methods for anatomical support.

Lastly, choices of compositions, sizes, and strengths of variousaforementioned elements, components, and steps all depend upon intendeduses thereof. Accordingly, these and other various changes ormodifications in form and detail may also be made, again withoutdeparting from the true spirit and scope of the invention as defined bythe appended claims.

Single Incision Incontinence Treatment Device

The features of the various exemplary embodiments described in thisapplication are suitable and intended to be combined with each other,unless specifically noted otherwise.

Anterior means “forward” or “front,” and posterior means “rearward” or“back.” Relative to surfaces of an organ in the human body, an anteriorsurface of an instrument inserted into the organ will be orientedforward toward the belly and a posterior surface will be orientedrearward toward the spine.

End means an end-most location and end portion means that segmentadjacent to and near the end of an object. For example, two opposingends of an object are each equidistant from a mid-point of the objectand between the mid-point and each end of the object is an end portionof the object.

Soft tissue is tissue other than bone. Soft tissue is not bone.

Embodiments provide a combination of anchors, including the anchors 120,136 described above and the anchor 1442 described below, employed tofixate a support in soft tissue in treating urinary incontinence. Theanchors and support are implantable through a single (one and only one)incision to support the urethra.

Embodiments provide a tissue anchor having a geometric asymmetry andasymmetric mass distribution along a length of the anchor whichencourages the anchor to be rotated into a stable configuration in thetissue.

Embodiments provide a tissue anchor that is adjustable by capturing asuture in sliding arrangement between a body and a collar of the anchor.Such an anchor can be provided as a fixed anchor when the suture isfixed between the body and the collar of the anchor.

Embodiments provide a system including anchors attached to a support,where the anchors are attached to the support and include a combinationof the anchor(s) having the geometric asymmetry and the asymmetric massdistribution along a length of the anchor and non-adjustable andadjustable tissue anchor(s) with a suture located between the body andthe collar of the anchor.

Embodiments provide a tissue anchor system having an anchor that willdurably anchor into periosteum tissue covering a bony surface, ordurably anchor into dense fibrous tissue where muscle inserts into thebone. An anchor so anchored is suitable for suspending support materialor is useful in implanting devices in the human body.

Embodiments provide a tissue anchor system including an introducer thatis configured to deliver an anchor to an intracorporeal tissue site. Theintroducer includes a cannula that allows placement of an anchor at alandmark in tissue deep within an incision site, which may be out of thefield of vision of the surgeon. The anchor is configured to be securedwithin the cannula so that it does not rotate or fall out of the cannuladuring insertion into the tissue. A length of suture is provided that isattached to the anchor, where the suture may be tied or otherwiseterminated to itself outside of the incision site and then subsequentlydirected to the intracorporeal landmark.

Embodiments provide a tissue anchor system provided to treat maleurinary incontinence that is advantageously implanted through a singleincision formed in the patient. A first anchor is anchored to the tissueof a first obturator foramen of the patient, and a second anchor isanchored to the tissue of a second obturator foramen of the patient tosecure in inferior portion of the support material to the patient. Athird anchor is provided to anchor a first pre-pubic arm to theperiosteum tissue on one side of the pubic symphysis, and a fourthanchor is provided to anchor a second pre-pubic arm of the supportmaterial to the periosteum tissue on the other side of the pubicsymphysis. Each of the anchor assemblies includes a suture extendingfrom the anchor to the support.

In one approach, the surgeon is instructed to suitably terminate ortighten the suture to capture the support material between a knot formedin the suture and the anchor implanted in the tissue. The surgeon,guided by experience and instruction provided with the tissue anchorsystem, first centers and fixates the inferior portion of the supportmaterial relative to the obturator foramen by suitably tensioning andtying knots in the suture. Subsequently, the surgeon centers and fixatesthe superior portion of the support material near an upper portion ofthe pelvis on either side of the pubic symphysis. Some aspects of thetissue anchoring system include a separate plication mechanism providedto take up the slack in tension the support material over the tissue ofthe urethra.

Embodiments of the system described in this specification provide asupport material that is implantable into the patient through a singleincision with anchor assemblies that do not create a second or otherincisions/openings in the skin. The system obviates the use oftransobturator arms and additional tools that tunnel the pre-pubic armsunder the skin. The system is easier to implant compared to a four armor six arm support, and reduces the amount of time that the patient isin the operating room.

One approach to treating urinary incontinence places a support inferiorto the urethra and directs arms upward from the support alongside thebladder along a U-shaped pathway. A significant advance over theU-shaped pathway was provided by Dr. Emmanuel Delorme as described inhis U.S. Pat. No. 6,638,211 and included placing arms of a supportthrough the obturator foramen along a V-shaped pathway. This applicationprovides another advance in supporting the pelvic anatomy by recognizingthat support material can be robustly attached to the periosteum tissuethrough the use of an anchoring system. The anchoring system allows thesurgeon to place the support inside of the patient and directly fixatethe support to periosteum tissue that is present over the exterior ofthe pelvis bone. This approach does away with needles and other toolsthat tunnel the arms of a support through tissue. The anchoring systemdescribed in this application is compatible with a true single (onlyone) incision formed in the patient.

FIG. 27 is a top view of one embodiment of a tissue anchor system 1420(the system 1420) of an incontinence treatment device. The system 1420is illustrated in one useful form for delivery to an end-user healthcarefacility and includes opposing anchors 120 attached to opposing sides ofa support material 1422 by the interconnecting member 110, sutures 1424(1424 c, 1424 d) engaged with the support material 1422, an anchorassembly 1426 engaged with each of the sutures 1424 c, 1424 d, and a setof introducers 1428.

The incontinence treatment device of the system 1420 includes a support1422 having a base 1460 and two arms 1462, 1464 extending away from thebase 1460, and a system of anchors 120, 1442 c, 1442 d connected to thesupport.

With reference to FIGS. 2-4, the anchor 120 is provided as a firstanchor 120 having those features described above including a body 122defining a first central longitudinal axis, a collar 128 defining asecond central longitudinal axis with the collar 128 received over thebody 122 such that the first central longitudinal axis and the secondcentral longitudinal axis are parallel and laterally offset, and a firststrand 110 extending through the collar 128 and received between thebody 122 and the collar 128 with the first strand frictionally engagedby the body 122 and the collar 128 and secured to the support 1422.

Two adjustable anchors 120 are illustrated in FIG. 27. The surgeon willplace one of the anchors 120 into the tissue in the obturator foramenand then place the other anchor 120 into tissue of the opposingobturator foramen. The adjustable anchors 120 described above allow thesurgeon to adjust a location and tension of the support 1422 by pullingon the interconnecting member 110 after placement of the anchors. Twoadjustable anchors 120 provide the surgeon with more latitude foradjustment, however it is to be understood that one or both of theadjustable anchors 120 could be replaced with the fixed anchor 136described above.

The second anchor 1442 is described below and includes a pointed leadingtip 1502, a leading end portion 1500 extending from the leading tip1502, a trailing end portion 1504 connected to the leading end portion1500 with the trailing end portion 1504 terminating in a trailing tip1506 that is located opposite of the leading tip 1502. First and secondprotrusions 1510 are formed on opposing sides of the leading end portion1500 with each of the first and second protrusions 1510 extendingoutward in a radial direction perpendicular to a long axis of the secondanchor 1442. A tissue engaging fin 1446 is integrated with the leadingend portion 1500 and oriented in a direction perpendicular to the radialdirection of the first and second protrusions 1510. An eyelet 1448 isformed through the tissue engaging fin 1446 with a second strand 1424inserted through the eyelet 1448 and secured to the support 1422. Agripping tab 1440 is removably attached to the tissue engaging fin 1446.

The support material 1422 is provided to support the urethra whenimplanted in the patient. Suitable materials for the support material1422 include autograft material (the patient's own tissue), allograftmaterial (tissue from a cadaver), xenograft material (tissue fromanother species), or synthetic materials such as woven fabrics, knittedfabrics, meshes, nonwoven fabrics, meshes, fibrillated fibers, or spunand fibrillated fibers. In some embodiments, the support material 1422is fabricated to include voids (pores) configured to allow tissueingrowth into the support material 1422. The pores are generally larger,on average, than 75 μm. One suitable support material 1422 is a knittedpolypropylene mesh, where each strand of the mesh is knitted from apolypropylene filament.

The sutures 110, 1424 are threaded through or otherwise engaged with thesupport material 1422. Each suture 1424 is threaded through or otherwiseengaged with one anchor assembly 1426. One suitable suture 1424 isfabricated from a single monofilament of polypropylene that is threadedthrough both the anchor assembly 1426 and the support material 1422 toform a continuous closed loop of suture. In one embodiment, the trailingend portions of each suture 1424 are brought together and maintainedwithin a conduit 1429, and at least the ends of the suture 1424 arewelded (heat welded or sonically welded) together to maintain the endsof the continuous closed loop of suture in an organized fashion untilthe surgeon desires to break the suture 1424 at the point of the weld.In one embodiment, the weld is a break pad 1430 that is formed bycrushing the ends of the suture 1424 into a flat structure that is morebrittle than and easier to break than the suture 1424 is itself. Thebreak pad 1430 maintains the suture 1424 in an organized fashion untilthe surgeon desires to access the free ends of the suture 1424, forexample to tie a knot. In one embodiment, the welded break pad 1430 isformed through the ends of the suture 1424 and through the conduit 1429.The conduit 1429 advantageously allows the surgeon to identify whichsuture strand is associated with each portion of the support 1422 andalso manages the sutures into an organized bundle for ease of handlingduring implantation of the support 1422.

The anchor assembly 1426 includes an insertion tab 1440 that isremovably secured to an anchor 1442. The anchor 1442 includes a body1444, a tissue engagement fin 1446 attached to the body 1444, and aneyelet 1448 formed in the tissue engagement fin 1446. The suture 1424 isthreaded through the eyelet 1448 and gathered/secured at the break pad1430. The insertion tab 1440 provides a convenient handle for thesurgeon or the surgical staff to handle the anchor 1442. The length ofthe anchor 1442 is in a range from about 4-20 mm, which can present asmall area for grasping when a person is wearing surgical gloves. Theinsertion tab 1440 allows the surgeon or the surgical staff to handlethe anchor 1442 comfortably when loading the anchor 1442 into theintroducer 1428.

Each of the first anchors 120 is implantable into an obturator foramenof the patient through the use of one of the tools 600 (FIG. 11)described above. The introducers 1428 are employed to secure the anchorassemblies 1426 into periosteum tissue associated with the pelvis. Inone embodiment, the introducers 1428 are multi-purpose introducers thatare suitable to also and additionally pass one anchor 120 to thepatient's right side obturator membrane and a second anchor 120 to thepatient's left side obturator membrane.

Each of the introducers 1428 a, 1428 b includes a cannula 1450 extendingfrom a handle 1452, and an ejection mechanism 1454 including a button1456 that communicates with a rod/wire disposed within the cannula 1450.Movement of the button 1456 in a distal direction (forward) moves therod/wire in a distal direction, which acts upon the anchor 1442 to ejectthe anchor out of the cannula 1450. The introducers 1428 a, 1428 b havea “handedness” depending on whether the anchor 1442 is into a left or aright obturator foramen. However, each introducer 1428 a or 1428 b isequally well suited for inserting one of the anchors 1442 intoperiosteum tissue.

An optional a plication mechanism 1470 is engaged with the supportmaterial 1422. The plication mechanism 1470 operates to gather up anyslack that might be present in the support 1422 after implantation.

Each of the anchors 1442 include an insertion tab 1440 and engaged withthe support material 1422. The anchors 1442 are located between thesupport 1422 and the patient's body, and the conduits 1429 and the breakpads 1430 are located between the support 1422 and the surgeon. Thus,relative to the support 1422, the anchors 1442 are located posterior(distal the surgeon) and the conduits 1429/break pads 1430 are locatedanterior (proximal the surgeon).

Each of the anchors 1442 is engaged with the support material 1422 by arespective suture 1424, where each suture 1424 penetrates the support1422 at more than one location. In the embodiment illustrated, eachsuture 1424 penetrates the support 1422 at two locations. We studied theeffectiveness of the compression provided by the support 1422 inelevating and compressing the urethra and have determined that themultiplicity of penetrations of the support 1422 by the suture 1424provides optimal support to the urethra. For example, two penetrationpoints for the sutures 120 on each side of the base 1460 (fourpenetrations total for two sutures) provides excellent suspension of thebase 1460 between the obturator foramen when the support 1422 isimplanted. Two penetration points oriented on a diagonal line from aninterior location of an arm 1462, 1464 to an outside corner of each arm1462, 1464 for each suture 1424 has been determined to provide excellenttension to the support 1422 when implanted.

The support material 1422 includes a base 1460 associated with the firstanchor 120 that is provided to be anchored into a first obturatormembrane and a second anchor 120 that is provided to be anchored into asecond obturator membrane of the patient. The support material 1422additionally includes a first pre-pubic arms 1462 associated with athird anchor 1442 c that is provided to be anchored into the periosteumtissue on one side of the pubic symphysis, and a second pre-pubic arms1464 associated with a fourth anchor 1442 d that is provided to beanchored into the periosteum tissue on the other side of the pubicsymphysis. The support material 1422 is provided to the hospital or thesurgeon in a package with instructions for use.

In one embodiment, a plication mechanism 1470 is engaged with thesupport material 1422. The plication mechanism 1470 is provided to allowthe surgeon to remove slack from a central region of the supportmaterial 1422 after the base 1460 and the pre-pubic arms 1462, 1464 havebeen secured to tissue. In one embodiment, the plication mechanism 1470is a single strand of polypropylene suture that is looped into athree-circle configuration (a snowman configuration). When force isapplied to the free ends of the plication mechanism 1470, each of thecircles in the three-circle configuration is contracted to remove theslack from the central portion of the support material 1422. The endsfor the plication mechanism 1470 can be welded into a break pad, or aretied into a suitable knot to tension the support material 1422 againstthe tissue of the urethra. The plication mechanism 1470 may be removedfrom the support 1422 by the surgeon after implantation if it isdetermined that the support material 1422 is lying as desired over thetissue. In one embodiment, the plication mechanism 1470 includes aconduit provided to manage the loose ends of the plication suture.

One approach to attaching the support 1422 in treating male urinaryincontinence is made with reference to FIG. 27. The patient is placed ingentle lithotomy position with buttock at the edge of the table. A Foleycatheter is inserted into the patient, for example a 14 French Foleycatheter. A single (one and only one) incision (about 4-6 cm) is madevertically in the perineal tissue 1 cm anterior to the anus. The surgeonis instructed to dissect down to and isolate the ventral bulbous urethrakeeping the bulbospongiosus muscle intact. The surgeon is instructed toexpose the bulbospongiosus muscle and take down the central tendon 2 cmto provide urethral mobility and allow for sling re-approximation. Thesurgeon is instructed to dissect sufficiently to accommodate the entiresupport 1422 and for incorporation of a wound retractor.

The system 1420 is appropriate both for use in procedures where thesurgeon dissects the bulbous spongiosis muscle and in procedures wherethe surgeon does not dissect the bulbous spongiosis muscle, as dependsupon surgeon preference.

One of the anchors 120 is placed in the obturator foramen following atrans-obturator (TO) path that is referred to as a TO approach. Theintroducer 600 (FIG. 11) is directed through the incision using aninside-out technique to guide the anchor 120 through the membrane overone of the left or right obturator foramen. The introducer 600 isstarted along a passage about 2 finger breadths (approximately 4 cm)below the pubic arch. The shaft of the introducer 600 should be parallelwith the ipsilateral ischial pubic ramus. Using the thumb, push theintroducer 600 posterior past the ischial pubic ramus, advancing throughthe obturator membrane until a pop is heard or felt. Once the “pop” isfelt, rotate an additional % turn (thumb slide should be facing up). Theanchor 120 is thus inserted into the obturator externus muscle.

The surgeon is instructed to withdraw the first introducer 600 and placethe other anchor 120 on the contralateral side of the patient with theother introducer (600Left or 600Right). The interconnecting member 110or strand 110 is pulled to create tension on the support 1422 relativeto the implanted and secured anchor 120.

The arms 1462, 1464 are lifted to tension the support 1422 against thebulbous spongiosis muscle. While holding the arms 1462, 1464 in tension,a third anchor is loaded into the introducer 1428, and the introducer1428 is directed through the incision to guide the anchor 1442 under theperiosteum tissue but above the bone. Specifically, the surgeon isinstructed to place the tip of the introducer 1428 perpendicular to thetissue and gently press down to contact the pubic bone, skive along boneaiming toward the patient's ipsilateral shoulder maintaining contact forapproximately 1.5 cm, then allow the needle to rotate away from thebone, followed by pushing the anchor 1442 approximately 1 cm farther.The introducer 1428 and the anchor 1442 in the introducer 1428 may berepositioned as desired by the surgeon. The surgeon is instructed todeploy the anchor 1442 from introducer 1428 using the thumb advance 56and counter rotate to withdraw the introducer 1428 leaving the anchor1442 in the dense fibrous tissue of the periosteum. The introducer 1428and the anchor 1442 may be repositioned as desired by the surgeon untilthe anchor 1442 is physically expelled from the introducer. The surgeonis instructed to pull on the suture 1424 to seat anchor 1442 in thetissue to ensure integrity of the anchoring. The suture 1424 attached tothe anchor 1442 is pulled and the anchor 1442 turns or toggles to fullyengage the anchor 1442 in a sideways orientation relative to the line ofentry of the introducer 1428 in the periosteum tissue. The anchor 1442is engaged with the periosteum tissue to hold the support in tensionagainst the urethral complex. The fourth anchor is loaded into theintroducer 1428, and introducer 1428 is directed through the incision toguide the anchor 1442 through into and under the periosteum tissue onthe contralateral side of the pubic symphysis of the patient. Thesurgeon is instructed to remove the conduit(s) from the suture 1424followed by tying of a double overhand knot in the sutures 1424 to holdthe support 1422 in compression against the urethra.

The surgeon is instructed to center the support 1422 on thebulbospongiosus muscle, using a stay suture if desired. The surgeon isinstructed to retract the catheter from the glans penis. The surgeon isinstructed to remove the conduit 1429 from the suture 1424 and toseparate suture ends by pulling apart the break pad 1430. The surgeon isinstructed to tie a double overhand knot on both sutures to secure thesupport 1422 down onto tissue, taking care to keep the support 1422centered. The surgeon is instructed to drive the knot down towards theanchor 1442, keeping the support 1422 centered, to firmly secure theimplant for optimum urethral re-approximation. The surgeon is instructedto tie additional overhand knots to lock the support 1422 in place,followed by trimming and discarding the removed excess suture.

The knots are tightened to secure and stretch anterior portion of thesupport 1422 over the urethra to provide optimum compression. Tieadditional knots to lock in place, trim and discard excess suture. Thesurgeon may perform flexible cystoscopy to ensure appropriate coaptationof the urethra is achieved.

In this approach, the support 1422 is secured and suspended by thesutures 110 between the opposing obturator foramen and held in tensionagainst the bulbous spongiosis muscle of the urethra by anchoring twoanchors 1442 in the periosteum tissue on opposed lateral sides of thepubic symphysis. If the surgeon decides that additional gathering of thesupport 1422 over the urethra is desired, the surgeon will use theplication mechanism 1470 to take up any slack in the mid-region of thesupport 1422 to ensure appropriate elevation and support of the urethra.

FIG. 28 is a perspective view of the introducer 1428 a. The cannula 1450extends from the handle 1452 and terminates in an end 1480. The button1456 of the ejection mechanism 1454 is located on the handle. In oneembodiment, the button 1456 is curved in an arc that extends over anexterior portion of the handle 1452, which allows the surgeon tomanipulate the button 1456 conveniently and ergonomically with one handin either a left moving approach or a right moving approach in placingthe anchors 1442.

The end 1480 is formed on an end portion 1482 of the cannula 1450. Inone embodiment, the end portion 1482 of the cannula 1450 is formed tohave a constant outside diameter. In one embodiment, the end portion1482 of the cannula 1450 is formed to have a tapering outside diameterthat tapers from a first diameter D1 to a second diameter D2, wherediameter D2 is less than diameter D1.

In one embodiment, the ejection mechanism 1454 includes a wire/rodlocated inside of the cannula 1450 and connected to the button 1456.Movement of the button 1456 moves the wire/rod within the cannula 1450.When the anchor 1442 is inserted into end 1480 of the cannula 1450,movement of the button 1456 in a distal direction ejects the anchor 1442in a distal direction out of the cannula 1450.

The cannula 1450 may be straight or curved.

In one embodiment, the end portion 1482 is formed as a circular arc allwithin the same plane such that the end portion 1482 is neither helicalnor spiral.

In one embodiment, the end portion 1482 is formed as a circular arc in ahelical spiral. For example, the end portion 1482 extends between afirst segment 1484 and the end 1480, and the helical spiral of the endportion 1482 is formed such that the end 1480 is located a distancedistal outward and away from the first segment 1484.

FIG. 29 is a perspective view of one embodiment of the introducer 1428 awhere the end portion 1482 is formed as a circular arc within the sameplane P. In one embodiment, the end portion 1482 is oriented 90 degreesrelative to a straight segment 1486 of the cannula 1450.

FIG. 30 is a perspective view of one embodiment of the cannula 1450prior to inserting the anchor 1442. The cannula 1450 includes a bore1490 that is sized to receive the body 1444 of the anchor 1442 and aslot 1492 that is sized to receive the tissue engagement fin 1446 of theanchor 1442. In one embodiment, the end 1480 of the cannula 1450 is bentinward toward the bore 1492 to form an ejection ramp that is akin to aski ramp on a ski jump. In one embodiment, the end 1480 of the cannula1450 forms a point that is bent inward, where the point is on a side ofthe cannula 1450 opposite from a location of the slot 1492. The bent end1480 provides several advantages, including preventing the cannula 1450from digging into bone when the cannula 1450 is inserted underperiosteum tissue and encouraging the anchor 1442 to lift and toggleaway from the cannula 1450 when the anchor 1442 is ejected from thecannula 1450. In one embodiment, the bore 1492 is a circular bore havinga substantially constant inside diameter. Other geometries areacceptable for the shape of the bore 1492.

In one embodiment, the slot 1492 is provided with side walls 1494 a,1494 b that are parallel one relative to the other. The anchor 1442 isrelatively small compared to the human hand. The tab 1440 is provided toallow the healthcare worker to handle the anchor 1442 and insert theanchor into the cannula 1450. After the body 1444 of the anchor isinserted into the cannula 1450, the tab 1440 is snapped off from theanchor 1442. The tab 1440 is discarded. The body 1444 of the anchor 1442is sized to frictionally engage with the bore 1492 and the tissueengagement fin 1446 is sized to frictionally engage with the slot 1492such that the anchor 1442 does not fall out of the cannula 1450 untilactively and intentionally ejected by the surgeon operating the ejectionmechanism 54.

It is desirable to frictionally engage the anchor 1442 into the cannula1450 of the introducer 1428. The geometry of the bore 1492 and the slot1492 can be modified to encourage the frictional engagement between thecannula 1450 and the anchor 1442.

FIG. 31 is a top view, FIG. 32 is a side view, and FIG. 33 is an endview of one embodiment of a cannula 1451 having a tapered outsidediameter and a tapered slot 1492′.

FIG. 31 is a top view of the cannula 1451 having a slot 1492′ modifiedto increase frictional engagement with the anchor 1442 illustrated inFIG. 27. In one embodiment, the slot 1492′ is tapered. The slot 1492′ istapered by having the side walls of the slot 1492′ tapered at an angleT. In one embodiment, the angle T is 4 degrees and the side wallsconverge the width of the slot 1492′ from 1.1 mm down to 0.890 mm. Thetapered slot 1492′ ensures positive engagement with the anchor 1442. Inthis example, the inside diameter of the bore 1492′ is 1.6 mm and theoutside diameter of the cannula is 2.2 mm.

FIG. 32 is a side view of the cannula 1451, and FIG. 33 is an end viewinto the bore of the cannula 1451. In one embodiment, the outsidediameter of the cannula 1451 is tapered from a first outside diameterOD1 measured at a proximal portion down to a second outside diameter OD2measured at a distal portion, where the first outside diameter OD1 islarger than the second outside diameter OD2. The pointed end of thecannula 1451 is not bent to provide the ski slope that is provided bythe cannula 1450 (FIG. 30).

FIG. 34 is a perspective view and FIG. 35 is a side view of the anchorassembly 1426. The anchor 1442 of the anchor assembly 1426 includes alongitudinal midpoint M located in the middle of the length of theanchor 1442 as measured on the longitudinal axis B between ends 1502,1506. A leading end portion 1500 of the anchor 1442 extends from themidpoint M to a leading end 1502, and a trailing end portion 1504extending from the midpoint M to a trailing end 1506. The leading endportion 1500 is connected to the trailing end portion 1504 at themidpoint M. A vertical axis A bisects the length of the anchor betweenthe leading end 1502 and the trailing end 1506 and thus intersects themidpoint M.

The anchor 1442 has a geometric asymmetry where the anchor 1442 has morearea on the leading end portion 1500 (i.e., the left-hand side of theaxis A) then on the trailing end portion 1504 (i.e., the right-hand sideof the axis A). The anchor 1442 also has an asymmetric distribution ofmass relative to the axis A. In one embodiment, a longitudinal centralaxis B is drawn and intersects the vertical axis A. In one embodiment,the mass distribution of the anchor 1442 is asymmetric relative to theaxis A (i.e., weighted more to the leading end portion 1500) and is alsoasymmetric relative to the axis B (i.e., weighted more above the axisB). In this example, the center of mass CM is forward of the axis Atoward the end 1502 and above the axis B. The center of mass CM of theanchor 1442 is not necessarily located at the geometric midpoint M.

The tissue engagement fin 1446 is located asymmetrically on the anchor1442 relative to the midpoint M. In one embodiment, the tissueengagement fin 1446 is located along the leading end portion 1500 of theanchor 1442 to provide the anchor 1442 with a geometric asymmetryassociated with the leading end portion 1500. In one embodiment, theanchor 1442 includes a barrel 1510 located on the leading end portion ofthe anchor 1442 to provide the anchor 1442 with an asymmetric massdistribution relative to the midpoint M. The barrel 1510, in combinationwith the tissue engagement fin 1446, contribute to a distribution ofmass for the anchor 1442 that is predominantly distributed forward inthe anchor 1442, for example along the leading end portion 1500. Thebarrel 1510 and the eyelet 1448 provided in the tissue engagement fin1446, in cooperation with the asymmetric forward-biased massdistribution, allow the anchor 1442 to toggle, or turn, to move toensure engagement when inserted into tissue.

The tissue engagement fin 1446 includes a leading edge 1520 and atrailing edge 1522, and the anchor 1442 includes a leading surface 1530located on the leading end portion 1500 and the trailing surface 1532located on the trailing end portion 1504. In one embodiment, theinsertion tab 1440 is removably secured to the leading edge 1520 of thetissue engagement fin 1446. The insertion tab 1440 includes a marker orother indicia 1534 to provide visual guidance to the surgical staff thatis useful when loading the anchor assembly 1426 into the cannula 1450 ofthe introducer 1428 (FIG. 30). After the body 1444 and the barrel 1510of the anchor 1442 are inserted into the cannula 1450 of the introducer1428, the insertion tab 1440 is disconnected from (snapped off) from theanchor 1442. The anchor 1442 is retained within the cannula 1450 andprepared for insertion into tissue.

FIG. 35 illustrates one embodiment in which the tissue engaging fin 1446is triangular with a first side integrated in the leading end portion1500 of the body 1444, a leading side (e.g., leading edge 1520)connected between the pointed end 1502 and a vertex V, and a trailingside (e.g., trailing edge 1522) connected between the vertex V and thetrailing end portion 1504 of the body 1444, with the vertex V locatedoff of the longitudinal axis B.

When the anchor 1442 is inserted into tissue, the surgeon is instructedto provide a pulling force to the suture 1424 (FIG. 27) that is engagedwith the eyelet 1448, and this pulling force rotates the anchor 1442 toengage the leading edge 1520, the trailing edge 1522, and the trailingsurface 1532 in a stable position within tissue.

The anchor 1442 is both geometrically asymmetric and has an asymmetricmass distribution, both which encourage the anchor 1442 to turn by whichthe leading end 1502 is rotated in a clockwise (for example) manner toengage the edges 1520, 1522, and surface 1532 with the tissue. Theanchor 1442 is configured for insertion into periosteum tissue thatcovers bone. The bone provides a backstop or a hard surface thatprevents the anchor 1442 from penetrating into the bone. The bone,however, also provides a surface that might discourage the rotation ortoggle in of the anchor 1442 since the bone is substantially immovable.It has been discovered that the geometric asymmetry and the asymmetricmass distribution of the anchor 1442 is well-suited to allow the anchor1442 to turn and toggle in a short distance as the surgeon applies apulling force to the suture that is engaged with the eyelet 1448. Otheranchors having a geometric symmetry and a geometric mass distributionhave been found to not turn, or turn less slowly and over a greaterdistance, which can have the effect of the anchor not fully engagingwith the tissue and possibly having the anchor pull out of or exit itsinsertion point into the tissue. In contrast, the anchor 1442 has beendiscovered to provide rapid turning and toggling that provides excellenttissue engagement over a short engagement distance as the surgeonprovides force to the suture 1424 that is engage with the eyelet 1448.

FIG. 36 is a perspective view of the anchor assembly 1426 oriented toillustrate a crush rib 1540 located along a lower edge of the anchor1442 on a side opposite from the tissue engagement fin 1446. In oneembodiment, the crush rib 1540 extends from the leading end portion 1500back to the trailing end portion 1504. One suitable height of the crushrib 1540 is in a range from 0.5-4 mm, preferably from 1-3 mm. The crushrib 1540 is provided to ensure a positive frictional engagement of theanchor 1442 with the cannula 1450 (FIG. 27) of the introducer 1428. Thecrush rib 1540 is deformable and configured to be pressed in toward thebody of the anchor 1442 when the anchor 1442 is inserted into a cannula.The crush rib 1540 occupies any excess space inside of the cannula, withthe excess material of the crush rib 1540 compacted to fit inside thecannula in a friction-fit manner. The 1-3 mm height of the crush rib1540 allows the rib to be compacted-to-size as it is inserted into thecannula.

Suitable materials for fabricating the anchor assembly 1426 includepolymers in general, metal and metal alloys, composites, compositesreinforced with fibers, and other materials suitable for molding orextrusion. In one embodiment, the anchor assembly 1426 is fabricatedfrom polypropylene. Other polyolefins or polymers are suitable.

The anchor 1442 of the anchor assembly 1426 has a length extending fromthe leading end 1502 to the trailing end 1506 in a range from 2-30 mm,preferably 5-25 mm, and more preferably 10-20 mm. One suitable anchorlength has been determined to be about 11 mm from the leading end 1502to the trailing end 1506.

The exterior surface of the insertion tab 1440 can include a texturedgripping surface such as a stippled surface or another suitablystructured surface that increases friction when the surgical staffhandles the anchor assembly with the gloved hand.

FIG. 37 is a perspective view, FIG. 38 is a top view, and FIG. 39 is abottom view of the anchor 1442 without the insertion tab 1440. Theleading edge 1520 tapers to converge to a line 1521 or narrow surface1521 that allows the anchor 1442 to more easily penetrate tissue.

The tissue engaging fin 1446 extends away from the body 1444. In oneembodiment, the tissue engaging fin 1446 has a triangular shape with alongest side X of the triangle parallel with the longitudinal axis B-Bof the anchor 1442, and shorter sides Y and Z meeting at an angle F, thethree sides X, Y, Z of the triangle defining a geometry of the tissueengaging fin 1446.

The tissue engaging fin 1446 is configured to grab in tissue andencourage the anchor 1442 to rotate for stabile engagement and anchoringwithin tissue. One embodiment provides the tissue engaging fin 1446 witha uniform width or thickness. In one embodiment, the interior portionsof the triangle X-Y-Z are scalloped or thinned, such that the perimeterof the triangle X-Y-Z is thicker in width than the area inside of thetriangle X-Y-Z.

The crush rib 1540 extends longitudinally along a portion of the bottomsurface of the anchor 1442. The crush rib 1540 is provided as a radiallyextending flange, where the flange has a width ranging between 0.1-0.5mm and a height in a range from 0.5-4 mm, preferably from 1-3 mm. In oneembodiment, the crush rib 1540 includes a tapering leading edge and atapering trailing edge. The crush rib 1540 is useful in retaining theanchor 1442 in the cannula 1450 of the introducer tool 1428 (FIG. 27)until deployment of the anchor 1442 is initiated. The crush rib 1540 issufficiently deformable when it is engaged with cannula 1450 to allowthe anchor 1442 to be press-fit into the cannula 1450 while alsoallowing the anchor 1442 to be ejected from the tool.

FIG. 38 is a top view of the anchor 1442. The leading edge 1520 tapersto converge to the line 1521 or ridge 1521.

In one embodiment, the leading edge 1520 tapers or slopes from apinnacle or vertex V of the anchor 1442 towards the body 1444 and thetrailing edge 1522 tapers or slopes from the vertex/pinnacle of theanchor 1442 towards the body 1444. In one embodiment, the leading edge1520 includes sloping surfaces 1523, 1525 extending from the line 1521toward first and second side surfaces 1527, 1529 of the tissue engagingfin 1446. The line 1521 and the sloping surfaces 1523, 1525 of theleading edge 1520 are configured to facilitate easy cutting or piercingthrough tissue during insertion and rotation of the anchor 1442 in thetissue. The configuration of the leading edge 1520 including the line1521 and the sloping surfaces 1523, 1525 provides the leading edge 1520with a reduced thickness (width) relative to a thickness of the fin 1446at the first and second side surfaces 1527, 1529, which aids the fin1446 in sliding through or piercing tissue.

In one embodiment, a top portion 1531 of the tissue engaging fin 1446has a generally cusped configuration with a base of the cusp locatedtowards the trailing edge 1522 of the fin 1446 and with the two sides ofthe triangle meeting on the line 1521. The cusped top portion 1531 isconfigured to help provide a smooth transition of the leading edge 1520between the line 1521 and the first and second side surfaces 1523, 1525.

In one embodiment, the trailing edge 1522 of the tissue engaging fin1446 has a blunt configuration and can include a planar surface. Thetrailing edge 1522 is configured to provide increased engagement withtissue such that the anchor 1442 has improved resistance againstextraction from tissue once it is in implanted in position.

With reference to FIG. 39, the surface 1530 of the anchor 1442 isintegrated with and angles away from the barrel 1510 to terminate at theleading end 1502. The bottom view of the anchor 1442 illustrates thatthe leading surface 1530 is heart-shaped as the wider barrel 1510 tapersto the leading end 1502.

In one embodiment, a width W3 of the tissue engaging fin 1446corresponds to the width W2 of the trailing end portion 1504 of the body1444. In one embodiment, the width W3 of the tissue engaging fin 1446 isgreater along one or more of the sides X, Y, Z of the triangular shape(FIG. 37) than at positions defined within the triangular area. That isto say, in one embodiment a wall thickness of the tissue engaging fin1446 is thinner “inside” the triangle's bounds than at one or more ofthe edges of the triangular shape.

In one embodiment, the tissue engaging fin 1446 is superposed over theleading end portion 1500 of the body 1444 including the protrudingbarrels 1510. The protruding barrels 1510 are formed as a pair of radialbarrels 1510 extending from the body 1444 in a radial directionperpendicular to the direction of the fin 1446.

In one embodiment, the tissue engaging fin 1446 is offset towards theleading end 1502 relative to the mid-point M of the body (located onaxis A-A in FIG. 34). In one embodiment, the tissue engaging fin 1446locates asymmetric to the mid-point M. In one embodiment, the tissueengaging fin 1446 is offset such that an entirety of the tissue engagingfin 1446 is located on leading end portion 1500. In one embodiment, amajority but less than an entirety of the tissue engaging fin 1446locates on leading end portion 1500. In one embodiment, the mid-point Mof the body 1444 locates at a transition between the leading end portion1500 and the trailing end portion 1504. In one embodiment, the eyelet1448 for receiving a length of suture extends through the entire widthW3 of the tissue engaging fin 1446.

FIG. 40 is cross-sectional view of the leading end portion 1500 of theanchor 1442 and FIG. 41 is cross-sectional view of the trailing endportion 1504 of the anchor 1442.

In one embodiment, the first and second protrusions 1510 combine withthe leading end portion 1500 of the body to provide the tissue anchor1442 with a circular cross-section.

The tissue anchoring system 1420 described above is useful for anchoringsupport material relative to tissue, particularly in treating urinaryincontinence. Embodiments provide placing the anchor 1442 in tissue,which can include ligaments, fatty tissue, connective tissue and othersoft tissue in general. It has been discovered that support materialuseful in treating male urinary incontinence can be implanted through asingle (one and only one) incision by employing the introducer 1428 andthe anchor 1442 described in this specification in placement of theanchor 1442 into periosteum tissue over the bone of the pelvis and otheranchors in the membrane of the transobturator foramen.

FIG. 42 illustrates the cannula 1450 of the introducer 1428 insertedinto soft tissue along a cannula path and guided along the bone of thepelvis and into periosteum tissue. Neither the cannula 1450 nor theanchor 1442 enter the bone. The anchor 1442 has been inserted into thebore 1492 and retained in the slot 1492 with the insertion tab 1440(FIG. 27) removed. The suture 1424 is engaged with the anchor 1442 bythe eyelet 1448 and exits through the incision made in the tissue. Inthis manner, the surgeon has control of the anchor 1442 by placingtension of the suture 1424, and also by having the anchor 1442frictionally engaged within the cannula 1450. In one embodiment, the end1480 of the cannula 1450 is bent upward toward the bore 1492 to reducethe possibility of the end 1480 digging into or gouging the bone.

FIG. 43 illustrates the anchor 1442 ejected a partial distance out ofthe bore 1492 of the cannula 1450 by the ejection mechanism 1454. In oneembodiment, the ejection mechanism 1454 is a piano wire connected to thebutton 1456, where the wire is stiff in axial compression and suited forpushing the anchor 1442 out of the cannula 1450 and yet flexible in aradial direction to allow the wire to negotiate the curvature of theintroducer needle or cannula 1450. Suitable ejection mechanisms 1454include piano wire, braided wires, or flexible cables fabricated ofmetal or plastic.

With additional reference to FIG. 27, the button 1456 of the ejectionmechanism 1454 has been moved forward in a distal direction, whichresults in the wire pushing the rod forward in a distal direction. Asurface of the rod pushes against the trailing edge 1532 of the anchor1442 to eject the anchor 1442 out of the cannula 1450 and into thesoft/connective tissue. The suture 1424 and the proximal portion of thecannula 1450 extend out of the incision toward the surgeon. The leadingend 1502 and the leading surface 1530 of the anchor 1442 are sized andconfigured to glide between the periosteum tissue and over the bone (butnot into the bone surface). The bent end 1480 of the cannula 1450prevents the cannula 1450 from digging into the bone and lifts theanchor 1442 away from the bone and begins rotation or toggling of theanchor 1442. The bent end 1480 of the cannula 1450 provides a ramp 1480,and movement of the anchor out of the cannula 1450 cause the anchor 1442to rotate away from the cannula path.

FIG. 44 illustrates the anchor 1442 ejected out of the cannula 1450. Thebent tip 1480 directs the anchor 1442 in an upward direction into theperiosteum tissue. The anchor 1442 is rotated off of the cannula path(the anchor 1442 is pitched upwards). In one embodiment, the anchor 1442has two rotational movements: one is rotated/pitched upwards off of thecannula path and the second is rotated (or rolled) on the longitudinalaxis of the anchor 1442. The cannula 1450 is removed from the tissueafter the anchor 1442 has been ejected. The surgeon controls theorientation of the anchor 1442 by maintaining control of the suture1424. The additional reference to FIG. 27, the suture 1424 is engagedwith the support material 1422 and includes the flattened break pad1430.

FIG. 45 illustrates the cannula 1450 has been removed from the tissueleaving the anchor 1442 in the periosteum tissue above the bone. Thesuture 1424 extends away from the anchor 1442 out of the incision by thecannula and back toward the surgeon.

FIG. 46 illustrates a top view of the anchor 1442 in an orientationafter a pulling force has been applied to the suture 1424. Pulling onthe suture 1424 in a direction away from the patient, rotates the anchor1442 to position a length of the anchor 1442 transverse to the cannulapath. The anchor 1442 is engaged with the periosteum tissue over thesurface of the bone; in this sense, the anchor 1442 is between the boneand the surface of the skin, thus located in the periosteum tissue.

The surgeon has directed a pulling forced onto the suture 1424 to rotatethe anchor 1442. The geometric asymmetry of the anchor 1442 and theasymmetric mass distribution along the length of the anchor 1442encourages the anchor to rotate into a stable configuration in which theleading edge 1520, the trailing edge 1522, and the training surface 1532are engaged with tissue and resist further movement of the anchor towardthe opening formed in the skin by the cannula 1450. The surgeon has thusforcefully engage the anchor 1442 in the periosteum tissue into anorientation in which the anchor resists displacement or movement. Thesuture 1424 extends the anchor 1442 to the support material 1422 (FIG.27). The anchor 1442 is thus engaged with tissue and the suture 1424 isengaged with the support material 1422. The surgeon has control of theanchor 1442 with the suture 1424, and in preparation for tying asuitable suture knot separates the suture 1424 into two free ends bybreaking the break pad 1430. The suture 1424 is tied in a suitable knotto retain the support material 1422 in the location desired by thesurgeon.

It has been discovered that the anchor 1442 engages with the periosteumtissue in such a forceful and durable manner that a polypropylene suture1424, as commonly employed in treating incontinence, will fail and snapbefore the anchor 1442 disengages with the tissue. That is to say, thepolypropylene suture 1424 has been designed to be the weak link in thesystem 1420 such that the anchor 1442 will forcefully engage withperiosteum tissue to allow the surgeon to apply as much force as desiredand fixating the support material 1422. The suture 1424 will breakbefore the anchor 1442 can be pulled out of the tissue, whichcontributes to a superior anchoring connection. The surgeon is familiarwith the amount of force that can be applied to polypropylene suture.

The procedure described above places the anchor and the periosteumtissue that covers the pelvis. The system 1420 is suited for placing theanchor 1442 in other locations, for example through the membrane of theobturator foramen. In such a procedure, the cannula is directed throughthe single incision formed in the patient, around the ischial pubicramus and into the membrane covering the obturator foramen. One suitablesuch cannula includes the cannula 1450 described in FIG. 29 having thecurved section 82. The ejection mechanism 1454 is employed to deploy theanchor 1442 into the membrane or muscle formed over the obturatorforamen. The suture 1424 is employed to fully engage the anchor 1442 inthe tissue prior to the surgeon fixating the support material 1422 bytying a knot and the suture 1424.

One suitable method for placing an anchor into tissue includes directingthe cannula 1450 of the introducer 1428 into the tissue; pushing theanchor 1442 out of the cannula 1450; removing the cannula 1450 from thetissue and leaving the anchor 1442 in the tissue; applying a pullingforce to the suture 1424 that is connected to the anchor 1442 to engagethe anchor 1442 with the tissue; breaking the bond that is formed in thesuture 1424 at the break pad 1430 to produce two free ends of the suture1424; and tying a knot in the suture 1424 to fixate the anchor 1442, orthe anchor 1442 and the support material 1422, in position as desired bythe surgeon and instructed in the instructions for use of the system1420.

One advantageous embodiment of the system 1420 includes providing thesurgeon improved control over when and where the anchor 1442 is placed.For example, it is sometimes experienced that when an anchor isdelivered into tissue by an introducer that the tissue has aninsufficient ability to retain the anchor. This phenomenon isexperienced when the needle is directed into fatty tissue, after whichthe surgeon realizes that the fatty tissue will be unable toappropriately retain the anchor for treating male incontinence. Thesystem 1420 provides a solution by allowing the surgeon to direct thecannula 1450 into the tissue to determine if the tissue is suited forreceiving the anchor, and allowing the surgeon to remove both thecannula 1450 and the anchor 1442 if the surgeon determines the tissue isnot ideal for the application. The system 1420 allows the surgeon todirect the cannula at another location in the tissue prior to ejectingthe anchor 1442 out of the cannula 1450 with the ejection mechanism 54.The system 1420 provides the surgeon improved control in that the anchor1442 does not leave the cannula 1450 until the surgeon activates theejection mechanism 54.

One suitable method of anchoring a support material for treating maleurinary incontinence will now be described with reference to FIG. 27.The two anchors 120 are implanted in the muscle of the obturator foramenthrough the use of the right hand tool 600R and the left hand tool 600L.The base 1460 of the support 1422 is thus suspended by the sutures 110and the opposing implanted anchors 120. A member of the surgical staffgrasps the anchor assembly 1426 by the insertion tab 1440 and insertsthe anchor 1442 into the cannula 1450. The insertion tab 1440 issubsequently removed from the anchor 1442. The suture 1424 is engagedwith the eyelet 1448 of the anchor 1442 and with the support material1422. The surgeon directs the cannula 1450 to the periosteum tissuelocation of interest and ejects the anchor 1442 by activating the button1456 of the ejection mechanism 54. The surgeon removes the cannula 1450from the tissue and applies a retraction force to the suture 1424 thatrotates and engages the anchor 1442 with the tissue. The supportmaterial 1422 is placed in the desired location, the break pad 1430 isseparated to provide the suture 1424 with two free ends, and the surgeonfixates a support material 1422 at the desired location. It should benoted that the surgeon also has the option to lightly tie a stay stitchto hold the support material 1422 in place until the other anchors aredeployed.

One application of the above method includes forming one and only oneincision in the patient between the scrotum and the anus, and fixatingthe anchors 120 into a respective one of the obturator foramen throughthe use of one of the introducers 600 (FIG. 11). The base 1460 of thesupport material 1422 is located inferior to the bulbar urethra and astay stitch is placed with the suture 110. A similar approach isemployed on the contralateral side of the patient to place the anchor120 in the opposing obturator foramen membrane. The surgeon pulls on thesuture 110 to tension and fixate the base 1460 of the support material1422 at a location inferior to the bulbar urethra.

The pre-pubic arms 1462, 1464 are elevated to a location superior to thebase 1460 and a mark is made on the tissue with a marking pen toidentify the location of the pre-pubic arms 1462, 1464. It is desirablethat the support material 1422 elevates and compresses the tissue of theurethra, and in one embodiment the surgeon will place additional markson the tissue at a location approximately 1 cm superior to each of thepre-pubic arms 1462, 1464 and 1 cm lateral and outside of each pre-pubicarms 1462, 1464 (i.e., the marks are “up and over” relative to thearms). A suitable cannula is selected, and the anchor 1442 c is loadedin the cannula. The cannula is directed into the periosteum tissue andthe anchor 1442 c is ejected from the cannula into periosteum tissueabove the surface of the bone of the pelvis. The cannula is withdrawnand a force is applied to the suture 1424 c to toggle and engage theanchor 1442 c within the tissue. With the pre-pubic arm 1462 placed inits desired position the surgeon will lightly tie a stay stitch in thesuture 1424 c. A similar approach will be employed on the contralateralside of the patient in which the anchor 1442 d is placed in theperiosteum tissue by a cannula of the introducer, after which thecannula is removed and the anchor 1442 d is rotated or moved intoengagement with the tissue by applying a force to the suture 1424 d. Thepre-pubic arms 64 will be placed in its desired position according tothe instructions for use provided with the system 1420, and the surgeonwill tie a permanent knot to fixate the pre-pubic arm 64. The surgeonconfirms the location of the placement of the pre-pubic arm 1462,loosens the stay stitch in suture 1424 c, and ties a permanent knot inthe suture 1424 c to fixate the pre-pubic arm 1462. In this manner, thepre-pubic arms 1462, 1464 are separated away from the base 1460 andfixated to elevate and compress the support material 1422 against theurethra. If desired by the surgeon, the plication mechanism 1470 isadjusted to remove slack from a central region of the support material1422 after the base 1460 and the pre-pubic arms 1462, 1464 have beensecured to tissue. The one and only one incision is closed in a suitablemanner desired by the physician and the patient begins recovery.

FIGS. 47A-47J are schematic views of embodiments of a process forimplanting the tissue anchor system 1420 illustrated in FIG. 27 in aperson to treat urinary incontinence.

In preparation for the surgery, the patient is reclined in a lithotomyposition, the sterile field is defined with appropriate draping, and theskin of the patient is suitably prepped according to the guidelines ofthe healthcare facility. The packaging containing the tissue anchorsystem 1420 is opened and the instructions for use are made available,for example on a back table in the surgical suite.

The tool 600 is employed to implant the anchors 120 in tissue of theobturator foramen and the introducer 1428 is employed to place each ofthe anchors 1442 into tissue of the patient, and these procedures areaccessed through a single incision. The single incision is the one andonly one incision formed in the skin of the patient. One useful incisionis a midline incision formed between the scrotum and the anus of a malepatient to provide axis to the bulbar urethral complex. Some surgeonsdissect the bulbous spongiosis muscle to access the urethra and thesystem 1420 is appropriate for this approach. Other surgeons do notdissect the bulbous spongiosis muscle, but rather access the urethracomplex and the system 1420 is also appropriate for this approach. Adilator or retractor of some sort is typically used to force theincision to an expanded position that provides access to the pelvictriangle. The dilator is not illustrated, but the incision isillustrated as an expanded circumferential area.

FIG. 47A is a schematic view of the support 1422 located in the surgicalfield and ready for placement within the patient. The adjustable anchors120 will be placed in each of the opposing obturator foramen and thetension in the sutures 110 adjusted, and then the anchors 1442 will beplaced in periosteum tissue over the pelvis on each side of the pubicsymphysis and the associated sutures 1424 will be adjusted andterminated. One or more of the adjustable anchors 120 could be replacedwith the fixed anchor 136 described above.

The following procedure will place the anchors 120 associated with thebase 1460 of the support 1422 in separate opposing obturator foramen(OF) of the patient. The anchor 120 is inserted in the patient's rightside OF and the suture 110 is allowed to trail out of the incision. Theother anchor 120 is inserted in the patient's left side OF and thesuture 110 is also allowed to trail out of the incision. The support1422 is positioned and the surgeon pulls on each of the sutures 110 toapply tension through to the support 1422, where the tension istransmitted through the implanted anchors 120. The suture 110 is slidthrough the anchor 120. The support 1442 is placed under increasedtension when the effective length of the supporting suture 110 betweenthe support 1442 and the anchor 120 is shortened. The anchor 120 allowsfor bi-directional adjustment, and the support 1442 can be loosened (thetension decreased) be lengthening the effective length of the supportingsuture 110 between the support 1442 and the anchor 120. Thus, the base1460 of the support 1422 is suspended by the sutures 120 implanted inthe muscle of the OF. The anchors 1442 c, 42 d attached to the pre-pubicarms of the support 1422 are subsequently attached to tissue of theperiosteum, and each suture 1424 c, 24 d is secured after both anchors1442 c, 42 d are implanted, as described below.

FIG. 47B is a schematic view of the right side introducer 600R (relativeto the patient) inserted through the incision and directed on a patharound the descending ischial pubic ramus (or, ischial ramus IR). Theanchor 120 is inserted onto the post at the end of the tool 600R. Theend of the tool 600R and the anchor 120 follow a path from the incision,around the IR and penetrates the membrane M of the obturator foramen OFto a location of the obturator internus muscle. An audible “pop” can attimes be heard as the anchor 120 enters the muscle of the OF. The tool600R is removed from the incision leaving the anchor 120 in theobturator internus muscle. The surgeon applies a force to the suture110, and the suture slides relative to the anchor 120 to position thesupport 1422. Additional tensioning is applied based on the surgeonpreference.

FIG. 47C is a schematic view illustrating the base 1460 of the support1422 located in one desirable position with the second anchor 120 beingloaded onto the left-hand tool 600L. The anchor 120 will be inserted onthe patient's left hand side using the tool 600L that is provided with acurvature that is opposite from the curvature of tool 600R (the rightside introducer).

FIG. 47D is a schematic view of the left side tool 600L inserted throughthe incision, around the descending IR, and through the membrane Mcovering the obturator foramen OF. The anchor 120 is “popped” into theobturator internus muscle. The tool 600L is removed. The surgeon pullson the suture 110 to apply a desired level of tension to the support1422.

FIG. 47E is a schematic view of the support 1422 located behind theincision with the base 1460 maintained in a lateral orientation betweenthe opposing obturator foramen OF. The surgeon locates a desiredorientation for the base 1460 and suitably adjusts the sutures 110. Inthis way, the base 1460 is suspended between the sutures 110 and arespective one of the anchors 120. The pre-pubic arms 1462, 1464 areelevated to either side of the pubic symphysis PS.

FIG. 47F is a schematic view of the anchor 1442 d loaded into thecannula 1450 of the left side introducer 1428 b. The insertion tab 1440has been removed and discarded. The procedure allows for placement ofthe pre-pubic arm anchors 1442 c, 42 d with either the right sideintroducer 1428 a or the left side introducer 1428 b, as determined bythe preference of the surgeon.

FIG. 47G is a schematic view of the introducer 1428 d inserted throughthe incision to attach the pre-pubic arm 1462 to the left-hand side ofthe patient. The end 1480 of the cannula 1450 is inserted through theperiosteum tissue PT. The end 1480 of the cannula 1450 is bent/sloped orotherwise configured to allow the tip of the introducer to slide alongthe bone and avoid digging into the bone under the periosteum tissue PT.The button 1456 is manipulated to eject the anchor 1442 d out of thecannula and under the periosteum tissue PT and on top of the bone. Theintroducer 1428 b is removed from the incision. The surgeon applies apulling force to the suture 1424 that is connected the anchor 1442 d,and this force toggles and rotates the anchor 1442 d into a broadside-onposition that fully engages the anchor 1442 d with the periosteum tissuePT. The suture 1424 d extends from the implanted anchor 1442 d, throughthe pre-pubic arm of the support 1422, and out of the incision forsubsequent fixation.

Regarding one process of anchoring the anchor to tissue, and as thesteps are illustrated in FIG. 47G, another anchor is inserted into thebore of the same cannula 28 b that was employed in placing an anchorinto the tissue of the obturator foramen, and this other anchor isinserted in the cannula and into the incision and along a second cannulapath into periosteum tissue. This other anchor is ejected out of thebore of the cannula and into the periosteum tissue. The other sutureattached to the other anchor is pulled in a direction away from thepatient to rotate the other anchor to position a length of the anchortransverse to the second cannula path. The other continuous suture loopis broken to allow a knot to be tied to fixate the support over theperiosteum tissue.

FIG. 47H is a schematic view of the base 1460 of the support 1422suspended between the obturator foramen OF with the pre-pubic arm 1462secured to the periosteum tissue PT on the left-hand side of the patientby the anchor 1442 d. A fourth anchor 1442 c is inserted into thecannula 1450 of, in this instance, the introducer 1428 a. Again, theinsertion tab 1440 has been removed from the anchor 1442 c anddiscarded.

FIG. 47I is a schematic view of the introducer 1428 a inserted throughthe incision to fixate the pre-pubic arm 1464 on the right-hand side ofthe patient. The end 1480 of the cannula 1450 is directed through theperiosteum tissue PT. The end 1480 of the cannula 1450 will slide alongthe surface of the bone. When suitably placed between the periosteumtissue PT and the bone, the button 1456 is pushed forward to eject theanchor 1442 c out of the cannula 1450. The introducer 1428 b is removedfrom the incision. The surgeon applies a tension to the suture 1424 totoggle, rotate, and engage the anchor 1442 c within the periosteumtissue PT. At this point in the process, two anchors 1442 d, 1442 c areattached in the two pre-pubic arms and the associated sutures 1424 d,1424 c extend from the anchors 1442 d, 1442 c freely out of theincision.

The surgeon elevates both of the pre-pubic arms 1462, 1464 in tensionagainst the fixed base 1460 and terminates the sutures 1424 d, 1424 c.

FIG. 47J is a schematic view of the support 1422 suspended between theobturator foramen OF and the anchors 120 and fixated to the periosteumtissue PT by anchors 1442 c, 42 d. The support 1422 has been implantedthrough a single (one and only one) incision. The implanted anchors 1442combine with the sutures 1424 to hold the support 1422 in place and toelevate and compress the bulbar urethral complex in treating maleurinary incontinence.

FIG. 48 is a top view of one embodiment of a tissue anchor system 1620including two toggling anchors 1442 a, 1442 b and two adjustable anchors120 attached to a support material 1422. The toggling anchors 1442 a,1442 b are configured to be implanted in the muscle of each opposingobturator foramen using the introducer 1428 (FIG. 28). The adjustableanchors 120 are adapted to be implanted in the periosteum tissue oneither side of the pubic symphysis in the approaches discussed above. Itis possible to employ fixed anchors 136 attached to the arms 1462, 1464instead of the adjustable anchors 120. Implanting the support 1422 withthe anchors 1442 a, 1442 b, 120 offers a single incision implantablesupport suitable for treatment of male urinary incontinence.

FIG. 49 is a top view of one embodiment of a tissue anchor system 1720including four adjustable anchors 120 attached to a support material.Two of the anchors 120 associated with the base 1460 are configured tobe implanted in the muscle of each opposing obturator foramen using thetools 600R, 600L (FIG. 11). Two other of the anchors 120 are adapted tobe implanted in the periosteum tissue on either side of the pubicsymphysis in the approaches discussed above. Implanting the support 1422with the anchors 120 offers a single incision implantable supportsuitable for treatment of male urinary incontinence.

Embodiments described include anchors attached to a support by a suture,where the anchors include a combination of anchor(s) having thegeometric asymmetry and an asymmetric mass distribution along a lengthof the anchor and non-adjustable/adjustable tissue anchor(s) with asuture located between the body and the collar of the anchor.

What is claimed is:
 1. An incontinence treatment device, the devicecomprising: a first anchor assembly; a second anchor assembly; and astrand; wherein at least one of the first anchor assembly and the secondanchor assembly comprises an adjustable anchor that is positionallyadjustable along the strand, the adjustable anchor comprising: a bodydefining a longitudinal body axis, and a collar defining a longitudinalcollar axis, the collar comprising a wall, with the collar disposed overthe body to locate the longitudinal body axis substantially parallel andlaterally offset relative to the longitudinal collar axis; wherein thestrand extends through the wall of the collar and is located between thebody and the collar, with the strand extending around a portion of thebody such that the strand is frictionally engaged between the body andthe collar.
 2. The incontinence treatment device of claim 1, wherein thestrand extends around the body in a circumferential direction.
 3. Theincontinence treatment device of claim 1, wherein the body has alongitudinal channel for receiving an introducer needle.
 4. Theincontinence treatment device of claim 1, wherein the collar is disposedentirely around a circumference of the body.
 5. The incontinencetreatment device of claim 1, wherein the strand comprises at least onefilament.
 6. The incontinence treatment device of claim 1, wherein thestrand comprises a length of suture material.
 7. The incontinencetreatment device of claim 1, further comprising a mesh support.
 8. Theincontinence treatment device of claim 7, wherein the strand is coupledto the mesh support and the adjustable anchor is bi-directionallyadjustable along the strand and characterized by the strand beingfrictionally engaged between the body and the collar of the secondanchor assembly.
 9. The incontinence treatment device of claim 8,wherein the second anchor assembly comprises the adjustable anchor andthe first anchor assembly comprises a fixed anchor that is coupled to anopposite side of the mesh support relative to the adjustable anchor. 10.The incontinence treatment device of claim 1, wherein the adjustableanchor further comprises a plurality of flanges that are configured toengage with tissue.
 11. The incontinence treatment device of claim 1,wherein the adjustable anchor further comprises a plurality of flangesthat extend in a radial direction away from the longitudinal body axis.